[c09aa8]: / clusters / 9knumclustersv2 / clust_1882.txt

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Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM 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 weeks post-surgery\r\n* The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM analysis and notify the ECOG-American College of Radiology Imaging Network (ACRIN) operations office within three () 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 have adequate tumor tissue to meet the minimum requirement for submission
Enrolling institutions are reminded that submission of pre-treatment serum, tumor tissue and whole blood is required
Provide adequate tissue (core or incisional/excisional biopsy) prior to starting study treatment; this tissue will be used for PD-L 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 must have a tumor tissue form indicating availability of archived tissue from a previous surgery for glioblastoma, completed and signed by a pathologist
cm^ of available tissue for N= patients for correlative tissue studies; patients can enroll regardless of their tissue availability being checked beforehand but at least patients will need to have sufficient tissue by study accrual completion; tissue availability will be checked after patients are successfully enrolled
Known mutation of Rb in tumor tissue
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 CDKNA or MTAP in the subject's tumor tissue.
Tumor tissue for mandatory pre-treatment and on-treatment biopsies.
Confirmed availability of tumor tissue blocks or freshly cut tissue slides for NaPib testing.
If a fresh tissue sample is provided, a blood sample is required.
Must have provided tumor tissue sample, as follows:
Availability of an archival FFPE tissue specimen.
Availability of an archival or new pre-treatment tissue sample is required if molecular testing was not performed by Foundation Medicine. Any available tumor tissue sample can be submitted. The tissue sample must be submitted within weeks after enrollment Erlotinib
Tissue availability must be verified prior to registration; if tissue is unavailable, the study chair must be notified prior to enrollment; tissue blocks or slides will be sent to Dana Farber Cancer Institute; NF- patients, as well as those with optic pathway, including chiasmatic-hypothalamic lesions (with or without NF-) are not required to have a biopsy; all others are, if deemed safe by their clinical team\r\n* Note: All patients who have tissue available must also have a pre-treatment blood sample collected
Has provided tumor tissue from locations not radiated prior to biopsy.
Tumor tissue receptive to Wnt signalling in biopsy
Patients must have measurable disease or evaluable disease for the escalation phase; for the additional patients enrolled at maximum tolerated dose (MTD) for further evaluation of pharmacokinetic (PK) and pharmacodynamic (PD) endpoints (Expansion Arm A), for the -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 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
Other bone and soft tissue sarcomas cohort only: Subjects with other soft tissue sarcomas who have received at least one line of therapy.
Consents to provide tumor tissue sample for the measurement of recent TROP levels by immunohistochemistry, which means archived sample following last treatment or pre-DSa treatment biopsy (there is no minimum TROP expression level required for inclusion)
DLL-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 ? % of tumor cells.
Availability of tumor tissue is mandatory for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist; availability of tissue is not a requirement for study participation
Mandatory tumor tissue must be submitted
The subject must have an archived tissue sample such as a prior surgical sample or biopsy sample that is adequate for testing
Retroperitoneal soft tissue sarcomas
Availability of archival or freshly collected tumor tissue before study enrolment
Has archive tumor tissue from primary tumor or metastatic site (excluding bone), for which the source and availability have been confirmed.
Patients must have confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications prior to study enrollment
Patients must have tissue resected by transurethral resection of bladder tissue (TURBT) at the MD Anderson Cancer Center
Have submitted a tumor tissue sample, as follows:
Availability of fresh tumor tissue and/or archival tumor tissue at Screening
No tissue is obtainable at thoracoscopy
Availability of fresh tumor tissue and/or archival tumor tissue (obtained within years of the consent date) at Screening
Qualifying HRR mutation in tumor tissue.
Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
It is preferable that patients have an adequate tissue sample available for correlative studies evaluating SAG expression, cullin neddylation, and KRAS^GD mutation, but lack of availability of such a tissue sample is not a requirement for trial enrollment
Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.
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 ~- grams tissue (\grape\ to \golf-ball\ size) or pleural fluid estimated volume ? mL (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.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART ): Confirmed MCL tissue diagnosis.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART ): Patients must be willing to allow residual tissue to be collected for both in vitro, in vivo (PDX) testing and molecular profiling.
Part patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of GBM, completed and signed by a pathologist
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 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 TM mutation in tumor tissue\n in Cohort A and the presence or absence of the TM 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 prior to dosing study drug but following\n disease progression on the first EGFR TKI
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist; availability of tissue is not a requirement for study participation
Unresected disease that meets the following criteria:\r\n* Scheduled to undergo definitive surgery (lumpectomy or mastectomy)\r\n* Tumor size >= cm (radiographically or clinically)\r\n* Grade or tumor or Ki- proliferation index of >= % (or both)\r\n* Any estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor (HER) status; however, receptors must have been tested on a diagnostic specimen\r\n* NOTE: bilateral cancers are eligible as long as at least 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
Tumor tissue must be sent; if tumor tissue is unavailable, the study chair must be notified prior to enrollment
Intent to submit tissue for central HER testing
KRAS or NRAS mutation detected in tumor tissue specimen
Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of and up to slides of archived tumor tissue or new biopsy, if archived tissue is unavailable for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible.
Tumor specimen availability
Availability of recent tumor tissue with months prior to enrollment, when feasible.
Availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment
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 ? days prior to Day .
Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening
Availability of archival or freshly collected tumor tissue before study enrollment
Archived tumor tissue (minimum of slides for paraffin-embedded tumor tissue) for assessment of tumor-based biomarkers and immune score is required for eligibility
Availability of tumor tissue sufficient for confirmatory testing of FGFR and q amplification status
Patients must to have tumor tissue collected prior to enrolling on this trial; up to 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
Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
Patients must have provided consent for tissue collection for the molecular testing through participation on study UPCC entitled; PROTOCOL TO PERMIT THE ACQUISITION OF SAMPLES OF TUMOR AND NORMAL TISSUE FOR BIOLOGICAL ENDPOINTS IN PANCREATIC CANCER
Tumor tissue is positive for EBV
Must consent to allow submission of archived tumor tissue sample from definitive surgery.
Confirmation of the availability of a tumor sample from the primary or recurrent cancer must be provided
Availability of tissue if applicable (from the primary tumor or metastases) for correlative studies.
Availability of tumor sample:
Availability of tumor tissue specimen
HER-overexpression in the patient's tumor tissue
Availability of tumor tissue sample that can be used for assessment of PrR levels with the use of immunohistochemistry;
Histological tumor tissue specimen
Must consent to allow submission of adequate archived tumor tissue sample from definitive surgery for genomic assessment of tumor.
Availability of archival tumor tissue
Availability of adequate tumor tissue for exploratory analysis and plan to obtain the material
Invasive primary tumor or metastatic tissue confirmation of HER-positive status, defined as presence of one or more of the following criteria
Patients with pathologically proven diagnosis of grade - (intermediate or high grade) soft tissue sarcoma with size >= cm are eligible to enroll if the intention to treat is curative; they must have sufficient tissue to submit to central laboratory for review as well as for NGS sequencing (see submission requirement); availability of tumor tissue is mandatory for study eligibility; the patient must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue for future central pathology review, NGS sequencing and/or translational research
Availability of tissue for HPV testing (paraffin block or one -m section on a slide).
Availability of tumor tissue for HER status confirmation
Methylated or hypermethylated MGMT promoter status within tumor tissue
Group B: Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.
Must submit tumor tissue for correlative analyses
Availability of fresh tumor tissue at screening
Availability of tumor tissue for central laboratory analyses.
Availability of fresh or archived tumor tissue.
Archived tissue sample or new biopsy sample.
Tissue availability for programmed cell death ligand (PD-L) 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 dose, preferably doses of nivolumab)
- Availability of tumor tissue from any time since diagnosis of prostate cancer disease. If no tumor samples are available the participant might still be eligible following discussion between the investigator and the medical monitor.
Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy o Tumor tissue from fine needle aspiration is not acceptable.
Availability of FFPE tumor tissue, either fresh core-needle-biopsied or archived
Availability of FFPE tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least days prior to randomization.
Confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications prior to study enrollment
Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy o Tumor tissue from fine needle aspiration is not acceptable.
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
Confirmed availability of archival or freshly collected tumor tissue
Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist
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
availability of tissue sample for diagnostic testing is required
Availability and willingness to provide sufficient tumor tissue sample for testing
Measurable soft tissue plasmacytoma
Consent to collection of a pre-treatment tumor sample, on-treatment biopsy, and, if applicable, a tumor tissue sample at the time of progressive disease (PD) Inclusion Criteria Specific to Obinutuzumab-Containing Cohorts
Patients only: must have a tumor in extremity muscle tissue or in the pelvis
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
Availability of archived tumor tissue sample that can be used for assessment of PrR status by the central laboratory;
Availability of archived tumor tissue for banking
Availability of tumor tissue (>= slides) for PD-L, gene expression profiling (GEP), and additional testing
Primary breast reconstruction in women at least 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
No use will be made of fetal tissue
Availability of tumor tissue at study enrollment
Tumor PD-L expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
Available tissue that was obtained at or after the time the usbject was found to have muscle invasive disease and is of suitable quality and quantity and to assess the FGFR status by genetic testing. For subjects participating in the Randomized Phase only, if suitable archival tissue is unavailable, then a core biopsy of tumor tissue (metastatic or primary) must be obtained prior to randomization even if a blood sample sample was used to determine FGFR genetic status
Biopsy of tumor tissue for central evaluation, within days prior to the first day of study treatment
HER-overexpression in the patient's tumor tissue
Tumor tissue EBV positive
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 younger than 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 , Expansion: tumor tissue