Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested).
Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory
Patients must have pre-treatment blood and tissue specimens submitted for translational medicine as outlined; with patient consent, residuals will be banked for future research
Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification\r\n* Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 21 weeks post-surgery\r\n* The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and notify the ECOG-American College of Radiology Imaging Network (ACRIN) operations office within three (3) weeks of receipt of the tumor tissue specimen via secure electronic messaging to the ECOG-ACRIN database; results will not be reported to the submitting institution\r\n* NOTE: Tissue must and can be submitted any time during screening period, even if patient is getting radiation\r\n* NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately
Patients must be offered the opportunity to submit archival tissue for translational medicine; patients must also be willing to undergo biopsies and submit fresh tissue and blood for translational medicine
Sufficient tissue and blood must be available to submit for required biology studies
Provide adequate tissue (core or incisional/excisional biopsy) prior to starting study treatment; this tissue will be used for PD-L1 analysis; fresh tissue or archival tissue sample can be used; if adequate tissue cannot be safely obtained than the patient may still be enrolled on the trial after discussion with the study principal investigator as long as fine-needle aspiration (FNA) was done to confirm recurrent/second primary head and neck squamous cell carcinoma (HNSCC)
Patients with recurrent diffuse intrinsic brain stem glioma (DIPG) that has an atypical presentation must also submit the tumor tissue for Rb1 protein status confirmation or provide previous testing results from a CLIA certified laboratory; patients who have been biopsied for atypical DIPG but do not have sufficient tissue for Rb1 screening are not eligible
Dose Escalation Cohort: archived tumor tissue or fresh tumor biopsy.
Expanded Cohort: archived tumor tissue and fresh tumor biopsy.
1 cm^3 of available tissue for N=5 patients for correlative tissue studies; patients can enroll regardless of their tissue availability being checked beforehand but at least 5 patients will need to have sufficient tissue by study accrual completion; tissue availability will be checked after patients are successfully enrolled
Patients who do not have available tissue for immunohistochemistry and nucleic acids analyses
Active skin or soft tissue infection including cellulitis, erysipelas, impetigo, furuncle,carbuncle, abscess, or fasciitis.
Phase II subjects must be willing to provide a tissue biopsy prior to registration if archived HCC tumor tissue is not available for correlative studies
Patients with pathologically documented metastatic triple negative breast cancer (TNBC), eligible for treatment with paclitaxel. Paraffin-embedded tissue must be available from metastatic sites, if reasonably accessible, or from the primary tumor, to confirm the diagnosis of TNBC and for correlative studies (only on metastatic tissue). Fifteen slides can be obtained if the full block is not available to be sent or released. TNBC will be defined as breast cancer with <1% ER+ and <1% PgR+ cells, and HER2 immunohistochemistry score of 0 or 1+ and/or in situ hybridization (ISH) with HER2 gene copy number <4 or a ratio of less than 2 between HER2 gene copy number and centromere of chromosome 17. Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER2.
For subjects with melanoma, archived or freshly biopsied tumor tissue (preferred) must be obtained prior to enrollment; tissue shipment tracking information should be provided before administration of study treatment is initiated; however, if shipping will be delayed and tissue shipment tracking information is unavailable, study drug may be administered prior to tissue receipt pending discussion with principal investigator
Have evidence of homozygous loss of CDKN2A or MTAP in the subject's tumor tissue.
Tumor tissue for mandatory pre-treatment and on-treatment biopsies.
Participants must have biopsy tissue at time of diagnosis available for targeted next-generation sequencing; the testing does not have to be completed prior to study enrollment; biopsy can be performed at an outside institution as long as sufficient tissue is available
Willing to provide blood and tissue from diagnostic biopsy and at the time of surgery
Patients with tumor tissue uptake during NETSPOT PET that is equal to or higher than that in normal hepatic tissue (grade >= 2) will be eligible; at the discretion of the principal investigator, patients with SCLC whose tumors have lower levels of uptake than liver during NETSPOT PET may be eligible for the study
Participants must have biopsy tissue at time of diagnosis available for next-generation sequencing testing at the Dana-Farber Cancer Institute; biopsy can be performed at an outside institution as long as sufficient tissue is available
Willing to provide archived tissue, if available, from a previous diagnostic biopsy
Memorial Sloan Kettering (MSK) patient has tissue available from a previous biopsy for the evaluation of potential predictive biomarkers; if tissue is not available for MSK patient, a new tumor specimen will need to be obtained prior to the start of study treatment; if archived tissue is available, participating site patient will provide for the evaluation of potential predictive biomarkers; if tissue is not available for participating site patient, a new tumor specimen is optional prior to the start of study treatment
Tumor tissue from biopsy following progression on the most recent TKI available for mutation analysis; if tissue is inadequate for exploratory research testing, patient may enroll with permission of principal investigator
Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrolment) Vismodegib
Tissue from the initial diagnosis or recurrence must be made available for correlative testing
Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
Patients must have tumor tissues from transurethral resection of the bladder tumor (TURBT) that is within 120 days of registration and available for submission; tissue sample must be sufficient for IHC testing; that is, it must be sufficient tumor tissues for correlative science after pathologic diagnosis (i.e., enough tumor tissue to pass the staging criteria)
Has provided tumor tissue from locations not radiated prior to biopsy.
Pathological diagnosis for the resected tumor demonstrates transformation to higher grade (i.e. WHO grade III or IV) gliomas; if a patient who received neoadjuvant vaccines is diagnosed as high grade glioma (HGG), the patient will be withdrawn from the study and considered for therapeutic options for HGG (trials for HGG or standard of care); the tumor tissue of such a case would be brought to the lab before the pathological diagnosis is made; and thus would be processed before the lab is informed of the final HGG diagnosis; because HGG tissue may still reflect the vaccine effects, we will evaluate the tumor tissue to help us develop future approaches for HGG
Tumor tissue receptive to Wnt signalling in biopsy
Donors who fail eligibility requirements for donation of cells or tissue for donation of a Human Cell and Tissue Products (HCT/P) will be excluded unless use of the cells complies urgent medical need or allogeneic use in a first-degree or second-degree relative
Diagnostic primary tumor tissue must be available for ERCC1 staining
Patients with breast tumors that are AR+ (?10% staining by immunohisto-chemistry). Archived tumor tissue from a primary biopsy or metastatic lesion for centralized determination of AR expression is mandatory. If tissue is limited, the additional correlative testing is optional. If tissue is not available, a patient will not be eligible for enrollment into the study. Patients may enroll based on local laboratory AR assessment, but will need to submit tissue for confirmation at the central laboratory.
Patients must have measurable disease or evaluable disease for the escalation phase; for the 6 additional patients enrolled at maximum tolerated dose (MTD) for further evaluation of pharmacokinetic (PK) and pharmacodynamic (PD) endpoints (Expansion Arm A), for the 6-patient breast cancer gene (BRCA)-mutation expansion arm, patients must have measurable disease; however, tumor biopsies are optional; for Expansion Arm B, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head and neck [H & N] lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements
Have pre-resection tissue (Esophagogastroduodenoscopy [EGD] or EUS biopsy from the diagnosis) available
Other bone and soft tissue sarcomas cohort only: Subjects with other soft tissue sarcomas who have received at least one line of therapy.
Consent to provide mandatory paired tissue biopsies, obtained within 6 weeks prior to the first study dose of CORT125281 and/or enzalutamide and at Cycle 2 Day 1 (soft tissue biopsy is preferred, when possible)
Available primary tumor tissue for CMS4 biomarker assessment.
Tissue specimen available for B7-H3 and PD-L1 expression testing
DLL3-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ? 1% of tumor cells.
Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available).
Fresh or archived tumor tissue sample available for target expression analysis. [Phase 1b only: Subjects' tumor tissue must test positive for target expression.]
Mandatory tumor tissue must be submitted
Be willing to provide archival tissue (if available) for correlative studies\r\n* Note: The archived tumor tissue specimens may be from metastatic tumor specimen (first choice); in alternative, we can consider tissue from prior surgery or from prior diagnostic biopsy (second choice); unavailability of archived tissue will not render subject ineligible for study
Patients with breast tissue expanders must have those removed before enrollment
Available tumor tissue for pathologic review and correlative studies; tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and/or blocks) to be sent to Duke
Have archived tissue available or be willing to undergo a fresh biopsy during screening, if deemed feasible by the investigator/study principle investigator (PI); if neither available, the patients enrollment must be reviewed and approved by the PI
Subjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes; in addition, subjects must consent to allow use of their residual post-operative tissue for research purposes
STUDY TREATMENT: Tumor tissue from the most recently resected site of disease (preferable) or from the transurethral resection that yielded the initial muscle invasive diagnosis must be provided for biomarker correlative analyses; enrollment is permitted if adequate archived tissue is unavailable
Patients must have histologically or cytologically confirmed malignant pleural mesothelioma; for phase 2 of this study only, the malignant tissue must show moderate or stronger mesothelin expression in 30% of tumor cells by a companion assay for the patient to be eligible for and registered to the study; for patients in pre-registration for phase 2, submit slides or a tissue block from an archived tissue sample or a fresh tissue sample from biopsy if archived tissue is not available to the central lab for the mesothelin expression assay; central review of pathology will not be performed
Consent for use of available archived tissue and tumor obtained during a standard procedure, for research purposes
Retroperitoneal soft tissue sarcomas
(For Cohort A) - Archived tissue available at pre-screening to confirm FR alpha+ breast cancer
Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted (prior surgical score, PSS, of 0 or 1)
Subjects must agree to pre-treament and on-treatment biopsies\r\n* Patients that have available tissue that fulfills the pre-treatment biopsy requirement or other deviations in terms of the tissue requirement, may not need a fresh biopsy at baseline if discussed and approved by the medical monitor
Positivity on CD44 assay as defined by strong (+++) or moderate (++) staining in 20% or more of the tumor tissue/stroma as obtained by biopsy or paracentesis
Tumor tissue from the core biopsy or resected site of disease must be provided for biomarker analyses
Agrees to provide available archived tumor tissue specimen; (patients who do not have available archived tumor must agree to have core or excisional biopsy of a tumor lesion obtained up to 42 days prior to the first dose of study drug, if safely accessible; if archived tissue is not available and the tumor is not amenable to safe biopsy, subject is still eligible to participate)
Must have a confirmed diagnosis of metastatic melanoma (cutaneous, acral-lentiginous, uveal and mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted
Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
Have tumor tissue for PD-L1 expression testing
If no archive tissue is available, the subject may elect to have a biopsy performed to obtain tissue.
Consented for tissue collection on Mays Cancer Center repository 07-32
Tumor must have dysregulation of the PI3K/AKT/mTOR pathway; for the purposes of this study, patients must have either PTEN protein or genomic loss, or PIK3CA/PTEN mutation; patients must be willing to provide sufficient archival tissue; if this is not available fresh tumor for biopsy is required; in the event that a patient has had tumor analyzed for PTEN/PIK3CA status through commercial means, their eligibility and need for additional tissue will be determined on a case by case basis by the principal investigator
Willing to donate tissue to research from the surgical specimen
Phase II archived tissue collection: will be requested when available, but is not mandatory for inclusion
Tumor tissue must be available for review to confirm histological diagnosis
For the neoadjuvant cohort, patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis; if evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study; for the CRPC lead in cohort, if histopathological documentation is unavailable, a rising PSA and a clinical course consistent with prostate cancer would be acceptable
Tissue available (archived or fresh tumor biopsy) for the PD-L1 assay
Willing to provide consent for an additional tissue biopsy for research purposes, to allow a part of their surgical tumor tissue to be utilized for research (in case tumor tissue has not already been saved in the tumor tissue bank), and to donate samples of blood and saliva collected weekly through the treatment
The patient must consent to a research biopsy at baseline, and during week 2 of cisplatin-IMRT; all patients will be evaluated for the feasibility of research biopsy at the time of enrollment, as a condition of eligibility; the performing physician must agree that a cup forceps biopsy or an 18 to 14 gauge core needle biopsy can be safely performed; every effort will be made to couple the baseline research biopsy to a standard of care diagnostic or staging procedure; NOTE: patients who have had research tissue procured under an omnibus tissue consent, who are determined to have sufficient fresh, fresh-frozen, and paraffin tissue for analysis of immune-inflammatory biomarkers per the translational science co-chair, may substitute the archived tissue and do not need to undergo baseline research biopsy; such tissue must have been obtained within the prior 24 weeks and no interval anti-cancer therapy administered
Patients at Washington University must be enrolled in HRPO# 201011766 (“Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases”); this is not a requirement for secondary sites; however, secondary sites must provide informed consent forms that document that permission for whole genome, whole exome, and/or genome wide sequencing, and data sharing among institutions, was obtained; because the study will also be sequencing non-diseased (normal) tissue, the informed consent forms must explicitly ask if patients wish to be informed, (or in the case of their death, their next-of-kin) if a deleterious mutation is identified in their non-diseased tissue, as this may be heritable
Pre-treatment tumor tissue available for research purposes; this tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy; this pre-treatment tumor must be amenable to repeat tissue sampling after induction therapy
History and/or current evidence of tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification
Consent for use of archived tissue for research purposes
History and/or current evidence of tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung with the exception of calcified lymph nodes and asymptomatic vascular calcification
At screening, must have tissue available for NY-ESO-1 testing (if not previously performed) or be willing and able to undergo a fresh tissue biopsy
Patients must have adequate fresh or frozen tissue available; if tissue is needed, then subjects may have had it collected previously under protocol PA15-0176
No tissue is obtainable at thoracoscopy
Biopsy containing ? 10 tissue cores sampled
Tissue submitted for HRG-biomarker testing
Phase II only: Biopsy of a metastatic lesion in patients with reasonably accessible metastatic lesions (chest wall, skin, subcutaneous tissue, lymph nodes, skin, breast, bones, lung, and liver metastases); if a reasonably accessible metastatic lesion is not available, the patient may go on study provided that archived tissue is available; however, if a reasonably accessible site is available for biopsy, the patient must agree to biopsy; any patients not undergoing biopsy must be approved for study enrollment by the Protocol Chair; biopsies may be done with local anesthesia or intravenous conscious sedation, according to institutional guidelines; if a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is clinically indicated, and excess tissue may be collected for research purposes; patients without sites available for biopsy must have available tissue (archived formalin-fixed paraffin embedded blocks [FFPB] or fresh frozen tissue from original diagnosis or metastatic setting) for correlative studies; tissue needs to be located and available at the time of registration (tissue needs to be submitted within 3 weeks of study initiation)
Subject has appropriate tissue available from the cytoreductive surgery for tumor lysate preparation
The subject must be expected to have an adequate amount of tumor burden to yield 2-4 pre-operative research core biopsy (14-gauge needle) specimens or the equivalent amount of tissue (4-6 mm punch biopsy), in addition, to the tissue required for diagnostic purposes
The subject must be expected to have an adequate amount of residual tumor after their pre-operative research tumor tissue collection, such that their operative research tumor collection will also yield at least 4-6 research core biopsy specimens or the equivalent amount of tissue
Tissue available (either initial diagnostic or recurrent tissue specimen) for p16 testing (if p16 status is already known, this criterion may be waived)
Patients who have tumor deposit(s) that are easily accessible by ultrasound or computed tomography (CT) guidance will be eligible for study; this is the case even in the event that a qualifying archived tumor sample is already available for a particular patient?qualifying archived tumor tissue is tissue extracted while the patient was in the same untreated state as when screened (usually tissue taken within 8 weeks prior to screening)
Tissue block of initial biopsy specimen is available
Patient does NOT have known intracranial metastatic neuroblastoma; skull based disease with soft tissue extension is allowed
Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites; if tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other Dana-Farber (DF)/Harvard Cancer Center (HCC) institution is required, but preliminary report only required prior to enrollment; if no tumor tissue was obtained, urinary catecholamine metabolites are required
Patients with the following histologies are excluded: melanoma, other soft tissue or bony sarcomas, giant cell tumor, aneurismal bone cyst or metastatic lesions from other histologies
Available tissue of primary lung tumor
Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
Subjects must provide samples of tumor tissue
Be willing to provide tissue
Planned standard of care surgical procedure (e.g., tumor biopsy or palliative resection or thoracentesis) and expected availability of a cumulative soft-tissue mass of ~10-30 grams tissue (\grape\ to \golf-ball\ size) or pleural fluid estimated volume ? 500mL (from a primary or secondary thoracentesis, yielding in a high volume of tumor cells) for immunotherapy manufacture.
Adequate archived primary or metastatic tumor tissue collected before the prior PARP therapy.
Willingness to provide pre- and post-treatment tissue for translational studies. Pre-treatment fresh frozen tissue must be available for research purposes. This tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy.
Must have diagnostic biopsy tissue (pre-neoadjuvant chemo) available for genetic testing.
Must have surgical tissue (post-neoadjuvant chemo) available for genetic testing.
Inadequate tissue acquisition to allow for neoantigen screening.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Confirmed MCL tissue diagnosis.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Patients must have relapsed/progressed after any therapy for MCL.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Patients must be willing to allow residual tissue to be collected for both in vitro, in vivo (PDX) testing and molecular profiling.
Tissue block of initial biopsy specimen is available
Patients must have adequate tissue (fresh or frozen) available or planned removal of adequate tissue for analysis; at least 250 mg of tumor are needed for peptide elution; there is no specific time limit on how long the tissue can remain frozen prior to use
Participants must have an image guided biopsy performed to yield fresh tissue for the in vitro organoid bio-assay and two biomarker testing (western blot and immunohistochemistry)
Stratum 2: Patients with DIPG who have pre-trial tumor tissue available are requested to submit tissue; however, this is not required for eligibility
The subject must have tumor tissue that is sufficient quantity and quality for sequencing
Patient is agreeable to allow tumor and normal tissue samples to be submitted for complete exome and transcriptome sequencing
At the point when tumor biopsies become mandatory (expansion phase only), disease amenable to biopsy and willingness to undergo biopsies or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration; criteria for the submission of tissue are:\r\n* Tissue must have been collected within 3 months prior to registration\r\n* Patient has not received any intervening therapy for their cancer since the collection of the tumor sample\r\n* Tumor tissue must meet the minimum requirements outlined
Central laboratory confirmation of the presence of the T790M mutation in tumor tissue\n             in Cohort A and the presence or absence of the T790M mutation in tumor tissue in\n             Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable.\n             Biopsy material obtained from either primary or metastatic tumor tissue and sent to\n             the central laboratory must be within 60 prior to dosing study drug but following\n             disease progression on the first EGFR TKI
Diagnostic primary tumor tissue must be available for biomarker correlatives, in both the dose-finding and expansion cohorts
Unresected disease that meets the following criteria:\r\n* Scheduled to undergo definitive surgery (lumpectomy or mastectomy)\r\n* Tumor size >= 1 cm (radiographically or clinically)\r\n* Grade 2 or 3 tumor or Ki-67 proliferation index of >= 10% (or both)\r\n* Any estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor 2 (HER2) status; however, receptors must have been tested on a diagnostic specimen\r\n* NOTE: bilateral cancers are eligible as long as at least 1 tumor meets the eligibility criteria above; if possible, tissue should be collected from both cancers at the time of tissue collection\r\n* A patient planning to initiate preoperative therapy who would like to take part in the study may do so if she agrees to undergo a study biopsy at the completion of digoxin dosing and prior to start of treatment, or at any time prior to start of treatment in those patients randomized to receive no drug; in these patients, tissue from the definitive surgery may still be collected for study correlates at the discretion of the protocol chair and pathologist
Intent to submit tissue for central HER2 testing
Available representative tissue from the most recent biopsy after the last therapy; if such tissue is not available, a fresh biopsy must be obtained
NSCLC and gastric adenocarcinoma subjects must have tissue available for HA-selection and PD-L1 testing.
Tumor tissue must be available for prospective determination of FGFR2b overexpression
Subject must consent to provide previously collected tumor tissue
adequate tumor tissue available prior to randomization
Participants in Stage 2 (Expansion) receiving erlotinib: i) sensitizing mutation in the EGFR gene and ii) consent to collection of tumor tissue samples before, during, and after treatment for biopsy and PD biomarker analyses.
Group 2 patients should have archived or fresh tumor tissue available from the non-craniotomy site and will have fresh tumor tissue available from the planned craniotomy
Can provide tumor tissue.
IHC greater than or equal to 20 percent of tumor on tissue sections must stain with NPC-1C.
Tumor tissue sections must be available for biomarker evaluation
For Parts B, C, D, E and F: Have available tumor tissue.
Subjects must be willing and able to have a fresh tumor biopsy prior to start of study treatment for research evaluations and cohort categorizing; Note: if insufficient fresh tissue is obtained to provide sub-classification for cohorts, then tissue material from a previous relapse biopsy and/or original diagnostic block may be requested to meet this criterion
Available TNBC diagnostic tumor tissue (archived tissue allowed)
Willing to provide tissue for translational research
Tumor tissue available from most recent biopsy to determine cell of origin
Must have available tumor tissue for TIM-1 expression testing
Lung cancer confirmed to express gpNMB, as assessed by immunohistochemistry at a central lab (using expression in ? 5% of tumor epithelial cells as a cut-off for positivity). This can be tested on archived tissue if available, although preferred tumor specimen is a biopsy after the most recent therapy.
FFPE tumor tissue either fresh core needle biopsied or archived (two FFPE cores preferred whenever possible) is required for participation in the study. If fresh tissue is obtained, the core biopsy must be done at least ?7 days prior to Day 0.
Screening for Rb applies to all patients with available tissue except for patients diagnosed with DIPG and bi-thalamic tumors.
Patients with diffuse intrinsic brain stem glioma (DIPG) can be enrolled without the need for available tumor tissue for RB protein status confirmation.
Mandatory tumor tissue available
Inadequate tissue acquisition to allow for neoantigen screening
Patient must agree to provide tumor tissue
Archive tumour tissue is available prior to recruitment for pharmacogenomic tests
Patients must to have tumor tissue collected prior to enrolling on this trial; up to 10 patients will be accepted with no pre-treatment research tissue collection or tissue collection from an outside institution\r\n* If the tissue is from an outside institution, it must be reviewed at Indiana University Health Pathology Department
Patients must have additional tumor available and be willing to submit tissue and blood samples
Patient must agree to provide tumor tissue from metastatic tissue at baseline
Patients must have provided consent for tissue collection for the molecular testing through participation on study UPCC 22210 entitled; “PROTOCOL TO PERMIT THE ACQUISITION OF SAMPLES OF TUMOR AND NORMAL TISSUE FOR BIOLOGICAL ENDPOINTS IN PANCREATIC CANCER”
Patient must agree to provide tumor tissue
Tumor tissue is positive for EBV
Tissue available for PD-L1 testing and for correlative science testing
RAS (KRAS and NRAS) wild-type in primary or metastatic tumor tissue
Consent for use of available archived tissue for research purposes
Active connective tissue disease
The participant has evaluable tumor tissue available for biomarker analyses.
Non-soft tissue sarcomas, such as osteosarcoma and chondrosarcoma are excluded
If patient has a clinically indicated surgery or biopsy at any time during treatment with Reolysin, a tissue sample will be collected for correlative research purposes
Consent for use of available archived tissue for research purposes
Tumor tissue available for evaluation of PD-L1 expression
Histological confirmation of node positive (any T stage N1-3) proximal esophageal, distal esophagus or gastroesophageal (GE) junction adenocarcinoma (Siewert I, II, or III) after completing preoperative chemoradiation and surgery; supporting pathology report sufficient for registration; available tumor tissue from endoscopic biopsies prior to preoperative chemotherapy (chemo)/radiation therapy (RT), and tumor from surgical specimens will be submitted to Academic and Community Cancer Research United (ACCRU), but not be required prior registration; Note: if tissue is depleted, patient will still be eligible after discussion with the physician
Patients must have histopathological documentation of adenocarcinoma of the prostate prior to starting this study and evaluable biopsy tissue (e.g., unstained slides or blocks) available for analysis; if evaluable tissue is not available, the patient must agree to undergo a pre-vaccination prostate biopsy on study as an alternative to having available tissue available
Have documented ALK positivity by a different test and tissue available for the Vysis® FISH test. Tissue should be derived preferably from a biopsy taken after progression with crizotinib. If such a sample is not available, testing may be performed with archived tumor tissue.
HER2-overexpression in the patient's tumor tissue
Have hormone-sensitive metastatic disease (M1) as evidenced by soft tissue and/or bony metastases
ASS1 deficiency (defined as ?50% ASS expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (IHC). For subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. A new tissue specimen obtained after most recent chemotherapy is not required. Thus ASS1 deficiency is required for entrance into the study. If tissue is not available to determine ASS1 deficiency, then tissue must be obtained by biopsy to determine ASS1 status.
Tissue is required prior to enrollment. If patient was diagnosed outside and tumor tissue is not available, a pleural biopsy for frozen tissue collection is required.
Histological tumor tissue specimen
Participants must agree to undergo a research biopsy of a reasonably accessible metastatic lesion (chest wall, skin, subcutaneous tissue, lymph nodes, skin, breast, bones, lung, and liver metastases); if a reasonably accessible metastatic lesion is not available, the patient may go on study provided that archived tissue is available; however, if a reasonably accessible site is available for biopsy, the patient must agree to biopsy; any patients not undergoing biopsy must be approved for study enrollment by the overall principal investigator at Dana-Farber Cancer Institute (DFCI); biopsies may be done with local anesthesia or intravenous conscious sedation, according to institutional guideline; if a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is clinically indicated, and excess tissue may be collected for research purposes; patients without sites available for biopsy must have available tissue (archived formalin-fixed paraffin embedded blocks [FFPB], blocks from which slides can be created, or fresh frozen tissue from original diagnosis or metastatic setting) for correlative studies; tissue needs to be located and available at the time of registration
All patients must have adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue; cases with limited tissue available should be reviewed with the primary investigator prior to enrollment
Patients must have histologically confirmed metastatic breast cancer; if available, tissue (a minimum of 3 slides) from the most recent biopsy should be submitted for review and confirmation of eligibility; NOTE: Material should ideally be from the metastatic disease, however material from the primary tumor is acceptable if that is all that is available; availability of tissue is not mandatory for confirmation of eligibility or enrollment to the study
A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA.
Consent to provide fresh tumor tissue during screening
Patients with evidence of soft tissue involvement by gross extranodal extension of tumor manifest by fixation to the fascia, or matting of nodal tissue that would compromise surgical resection as determined by the surgical oncologist
Tumor GANQ, GNA11, and BAP1 mutational status must be determined on all patients; if initial testing is performed locally or not available, MSKCC or Columbia University Medical Center (CUMC) patients must consent to provide a tumor block or unstained slides to MSKCC or CUMC for central review of mutational status; if tissue is not available, a pre-treatment biopsy will be necessary for eligibility \r\n* Patients enrolled at Vanderbilt University Medical Center may have GNAQ and GNA11 mutational status determined on a Clinical Laboratory Improvement Act (CLIA)-approved assay at Vanderbilt University Medical Center, CUMC, or MSKCC; tissue must be sent to MSKCC for BAP1 mutational status determination\r\n* The determination of mutational status may be performed retrospectively and will not delay patient treatment on study as long as tissue is available for molecular analysis
Invasive primary tumor or metastatic tissue confirmation of HER2-positive status, defined as presence of one or more of the following criteria
Presence of a BRAF V600E mutation in lung cancer tissue. Mutation must be locally confirmed in a CLIA-certified laboratory (or equivalent). An adequate amount of tumor tissue (archived tumor tissue, or fresh biopsy if archived tissue is not available) must be available at the time of enrolment for central validation of BRAF mutation;
inability to visualize the prostatic tissue adequately on transrectal ultrasound imaging;
Group B: Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.
Must have available tumor tissue and consent to biopsy while on study.
Must consent to allow the acquisition of new tissue biopsy samples during the study
Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within 60 days of the first day of study treatment, C1D1, and have tissue available to send to sponsor laboratories or are able to undergo a biopsy during screening and provide tissue to sponsor laboratories
Tumor tissue available at time of screening for molecular profiling.
Must submit tumor tissue for correlative analyses
Must have available tumor tissue and consent to biopsy while on study.
Baseline tumor tissue to conduct molecular and / or genetic studies should be available from all study patients enrolled in this study. (optional in Phase 1b)
Adequate tumour tissue (greater than 0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumour be made available for assessment of potential biomarkers.
Adequate amount and quality of tumor tissue from first surgical resection available for genetic profiling
Available tissue for AR testing for research purposes
Tissue availability for programmed cell death ligand 1 (PD-L1) expression is mandatory for enrollment; however if archived tissue is unavailable the patient will be given the option to consent to pre and post treatment tissue biopsies; tissue biopsies will be collected pretreatment (prior to the first dose of therapy) and post treatment (after at least 1 dose, preferably 2 doses of nivolumab)
Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2
Tumor tissue from the resected site of disease must be provided for biomarker analyses
Available archived tissue to perform molecular analysis\r\n* Patients without available archived tissue can have repeat biopsies to determine EGFR status as per standard clinical care guidelines
Sufficient archived tumor samples (if taken within 6 months prior to treatment may be submitted) available for PD assessments, or willingness to undergo a pre-treatment core needle biopsy, preferably of the primary tumor, in order to obtain such tissue;
Patients must provide tissue from a punch biopsy of the skin at baseline, at the time of a clinical event (at the time of response, progression or appearance of a new lesion) and at the end of treatment; additional punch biopsies every 3 cycles are optional; an archival tissue sample is optional
HCC tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status, and other biomarkers, to be performed retrospectively. Subjects with no tissue available would require a biopsy.
Must have submitted a diagnostic FFPE tumor tissue sample to confirm tumor GR positivity. Tumor tissue may be from primary or metastatic lesion. In the absence of sufficient tissue to complete IHC, a tumor biopsy will be required.
Availability of tissue from the initial diagnosis and the recurrent tumor that is estimated to be of sufficient quality and quantity for both genomic deoxyribonucleic acid (DNA) and total ribonucleic acid (RNA) isolation; preferably some of the tissue would be snap frozen for high quality RNA preparation
Molecular characterization of the tumor demonstrating a KRAS mutation by a CLIA-certified assay. Adequate archival tissue, tissue core biopsy specimen, or DNA samples must be available for central testing of INK4a/Arf and p53 if not previously performed by a CLIA certified lab.
Subjects have available tumor tissue
Tumor tissue (archived or fresh) is required and must be available to be shipped to GSK or site specific laboratory.
EGFR-mutation negative tumor tissue as determined by sequencing; if an individual tissue test result is inconclusive (unable to be determined), it will be considered negative for study eligibility purposes
Tumor verified to be CD20+ (based on local evaluation), from a current or previous tissue biopsy. Tissue biopsy should be repeated if no report or specimen is available, CD20 staining was not previously performed, or there is clinical suspicion that the indolent lymphoma has transformed to aggressive lymphoma/higher malignancy grade.
Measurable soft tissue plasmacytoma
Consent to research use of their BCC tissue
Patients must have a signed tissue acquisition consent and have at minimum, adequate samples of primary fresh tissue or blood available for use in this study.
Documentation of disease: \r\n* Histologic documentation: histologically proven mucosal melanoma by local pathology\r\n* Tumor tissue: tumor tissue from the primary site of disease must be available for PD-L1 testing (stratification factor)
Sufficient tumor tissue must be available for histologic assessment of PD-L1 expression and whole exome sequencing
Have pre-resection tissue (esophagogastroduodenoscopy [EGD] or EUS biopsy from the diagnosis) available
Tumor tissue available and deemed adequate for genomic studies
History or current evidence of:\r\n* Tissue calcification including, but not limited to, the soft tissue, kidneys, intestines, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification\r\n* Endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc
Unresectable thyroid cancer expressing TG as assessed by one of the following methods: real-time (RT)-polymerase chain reaction (PCR) on tumor tissue, or by immunohistochemistry of resected tissue
Subjects must have existing tissue available for correlative studies; if availability of tissue has been confirmed the study drug can be started prior to the tissue being obtained
Patients must be willing to submit blood and tissue specimens for translational medicine
Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction [tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement] to replace breast tissue post-mastectomy)
Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity)
Patients receiving osseocutaneous free tissue transfer regardless of the indication for free tissue transfer; this includes osseocutaneous tissue from fibula and scapula
Preoperative surgical plan: immediate placement subpectoral tissue expander with ADM
No use will be made of fetal tissue
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nBiopsy prior to study enrollment that is obtainable AND has sufficient residual tumor tissue from such biopsy is obtainable and donated for the research
Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
Passage through non-aerated lung or tissue
Absence of HER2 expression documented as ISH-negative on previously collected and assessed tumor tissue upon initial diagnosis of disease
Tissue available for the evaluation of AR by IHC on pretreatment HCC samples; if tissue is not available, a pretreatment biopsy will not be necessary for eligibility
Pre-treatment fresh frozen tissue available for research purposes; this tissue can be collected from preoperative laparoscopy, other diagnostic biopsy, or a research-specific biopsy
Non-surgical cohort only: positive phospho-EGFR assessment (>= 100 stained pixels) from tissue obtained from previous clinical liver biopsy
Willingness to provide blood and tissue samples for safety/toxicity monitoring and biomarker analyses
Consent to the tissue Cancer Therapy and Research Center (CTRC) biorepository
Patients with a known connective tissue disease
Breast patients with tissue expanders are not allowed with the exception of tissue expanders made of material that are MRI compatible; check with the MRI technician to confirm
Biopsy of tumor tissue for central evaluation, within 60 days prior to the first day of study treatment
HER2-overexpression in the patient's tumor tissue
Tumor tissue EBV positive
Patients must be willing to provide a core tissue biopsy at baseline and with repeat tissue collection after 12 cycles of protocol therapy
Patients must have an ability to understand and the willingness to sign a written informed consent document; the patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research
Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database
Willing to allow use or collection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available) or research only biopsy
Patient’s that have complex DCIS as indicated on radiology, which would require excising a large tissue volume
Patients must document their willingness to be followed for at least 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database
Subject with normal oral tissue
Those participants requiring surgical intervention for diagnostic and/or therapeutic purposes as necessary for their disease are eligible; the tissue may be assessed by histology and/or EM for iron particles; only clinically indicated biopsy and/or surgery will be done
UNC patients must co-enroll into LCCC9819 for collection of tissue samples
Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue (obtained before or after 20 weeks of Eovist® injection) from a soft tissue or metastatic bone lesion (measuring >= 1.5 cm in diameter at computed tomography [CT] or MRI scan) available for OATP1B3 expression or
Subjects, for whom tissue is not available, must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression
Have tissue block available from core biopsy for correlative biomarkers and genomic assay
Patients younger than 18 years of age with a histologically or cytologically confirmed diagnosis of cancer who are being treated for cancer at the NIH Clinical Center and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue collected
Tumor tissue:
Part 2, Expansion: tumor tissue
Patient must be willing to provide consent for use of archived tissue for research
DYNAMIC COHORT: Willing to consent to collection of pathology tissue for the purposes of research at the time of clinical biopsy or surgical procedure
Patients must be agreeable to provide tissue prior to enrollment
Soft tissue progression
Tissue confirmation.
Archive tumor tissue (obtained from a biopsy or surgical resection of a metastatic lesion done within 4 months from study enrollment) availability is required for patient participation. If the available tissue is insufficient for the required baseline analysis, the patients are given the option to repeat the biopsy for the purpose of study participation as long as they have not already started palbociclib or ribociclib.
Are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory).
Tissue must be available for genotyping or biopsy planned to obtain tissue for genotyping; biopsy requirement may be waived if not technically feasible and plasma genotyping reveals an eligible EGFR mutation (exon 19 del/L858R); determination of technical feasibility must be made independently of plasma genotyping results
has a substantial probability to cause an irreversible injury to any tissue and/or