[c09aa8]: / clusters / 9knumclustersv2 / clust_2989.txt

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Unless the pre-screening was performed at Yale Clinical Molecular Pathology Lab (YCMPL), patients must have TCC tumor tissue available for submission in a form of at least unstained slides or formalin-fixed paraffin-embedded (FFPE) block (FFPE block highly recommended and preferred) along with a buccal swab; if the number of slides is less than , a biopsy should be considered; if a biopsy is deemed unsafe, the case may be discussed with the study principal investigator (PI) and approval must be given for eligibility
Patients must have adequate tumor tissue available, defined as >= % tumor cells and >= . mm^ tumor volume\r\n* The local interpreting pathologist must review the specimen\r\n* The pathologist must sign the S Local Pathology Review Form confirming tissue adequacy prior to screening/pre-screening registration\r\n* Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Act (CLIA) biomarker profiling and c-MET IHC; if archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor block or FFPE slides - microns thick must be submitted; bone biopsies are not allowed; if FFPE slides are to be submitted, at least unstained slides plus an H&E stained slide, or unstained slides must be submitted; however it is strongly recommended that FFPE slides be submitted; Note: previous next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if done outside this study for sub-study assignment; patients must agree to have any tissue that remains after NGS testing retained for the use of the translational medicine (TM) studies (if such TM studies are defined) within any sub-study the patient is enrolled in
Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary tumor, mandatory\r\n* NOTE: for adjuvant patients this refers to the surgical specimen; for neoadjuvant patients, both the pre-treatment core biopsy and the surgical specimen with residual disease are requested but only one is mandatory; if the surgery tumor blocks are available, but cannot be submitted, sites may submit a portion of invasive tumor from the original block, either by taking at least one core of at least mm in diameter, or by splitting the original block in two parts, and re-embedding one in a new block for central submission; if blocks containing pre-neoadjuvant treatment core biopsies are available but cannot be submitted, sections mounted on glass slides prepared from the block can be provided; if tumor sample can't be provided as requested above or if it's not available, approval by study team for patient's entry into the trial is required
An adequate amount of archived tumor tissue, either from primary colorectal cancer site or metastatic lesions, for central confirmation of dMMR status:\r\n* Either whole or part of the formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue; or\r\n* At least unstained slides containing tumor sections
Patients must have undergone adequate (definitive) breast surgery for the current malignancy. FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.
Must consent to allow the acquisition of existing formalin-fixed paraffin-embedded (FFPE) tumor tissue, either a block or unstained slides, for performance of correlative studies
Tissue from a prior craniotomy or biopsy for clinical genetic sequencing (at least one formalin-fixed, paraffin-embedded [FFPE] block or unstained slides); patients previously assessed for genetic sequencing who meet requirements do not need to have additional tissue available for prospective genetic screening
Participants must have sufficient tissue from prior surgery revealing glioblastoma or variants for confirmation of diagnosis and correlative studies; the following amount of tissue is required:\r\n* ( um thick) unstained formalin fixed paraffin embedded (FFPE) sections\r\n* - hematoxylin and eosin (H&E) stained slides, or additional unstained um slide(s) for staining\r\n* NOTE: the overall principal investigator (PI) will allow for up to participants to enroll with insufficient tissue; if a site is hoping to enroll a patient with less than the tissue required, prospective approval by the overall PI is required
Availability of at least unstained slides from archival FFPE tumor tissue.
Either a formalin fixed paraffin block or a minimum of ten -micron tissue sections (slides) of tumor biopsy sample must be available for biomarker evaluation from baseline and repeat esophagogastroduodenoscopy (EGD)
Confirmation of availability of FFPE tumor specimen with adequate tumor tissue (either one paraffin embedded tissue block OR -micron unstained slides from the block on regular (non-plus) slides and hematoxylin and eosin [H&E] slide)
Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of ( preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. If only - slides are available, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases is not acceptable
Confirmed availability of archived FFPE tumor tissue block, or a minimum of slides. If archived FFPE tissue is not available, then fresh tumor sample may be obtained in accordance with local institutional practice for tumor biopsies.
Availability of archival tumor tissue for biomarkers analysis (formalin-fixed paraffin-embedded [FFPE] block or cell block will be required); specimen from primary site will be allowed; patients must have at least slides available; repeat biopsy to obtain sufficient tissue for slides is allowed
Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block; a recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, unstained slides [ minimum] will be acceptable) from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within years of trial screening; patients with tumor specimens older than years may still be eligible if deemed so by study sponsor
Available tumor samples:\r\n* A formalin-fixed paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a Response Evaluation Criteria in Solid Tumors [RECIST] target lesion); alternatively, a recently obtained archival FFPE tumor tissue block (cut slides not\r\nacceptable) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: ) the biopsy or resection was performed within year of enrollment AND ) the patient has not received any intervening systemic anticancer treatment from the time the tissue was obtained and randomization onto the\r\ncurrent study\r\n* Availability of an archival FFPE tumor tissue block from primary tumor resection specimen (if not provided per above); if an FFPE tissue block cannot be provided, unstained slides ( minimum) will be acceptable
A formalin fixed tissue block or equivalent of slides of the tumor sample for analyses by Adaptive Sequenta and NeoGenomics must be available for analysis
Patients must agree to have a biopsy of non-bone metastatic tissue at baseline, and there must be a lesion that can be biopsied with acceptable clinical risk as judged by the investigator\r\n* Patients with unsuccessful baseline biopsies or inconclusive DNA damage repair status testing (either MSI or FA/BRCA signature) may undergo an additional biopsy attempt (at the same or a different site, determined by the investigator)\r\n* Patients with previously identified homozygous deletion or deleterious germline or somatic mutation(s) in DNA damage repair gene(s) (such as BRCA, BRCA, and ATM) identified in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory are allowed in Group \r\n** Somatic mutation(s) in DNA damage repair gene(s) needs to be identified on the biopsy of a castration-resistant metastatic site\r\n** Archival formalin-fixed paraffin-embedded (FFPE) tissue will be requested for determination of MSI and FA/BRCA signature status\r\n*** A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report before study enrollment\r\n*** If archival FFPE tissue is unable to be obtained or is insufficient, patients will be required to undergo biopsy of a metastatic site if feasible for determination of MSI and FA/BRCA signature status\r\n* Patients with germline mutation(s) in mismatch repair (MMR) gene(s) (i.e. Lynch syndrome), or have previously identified MSI-high tumor by polymerase chain reaction (PCR) or MMR deficient tumor by immunohistochemistry (IHC) are also allowed in Group \r\n** Archival FFPE tissue will be requested for determination of FA/BRCA signature status\r\n*** A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report before study enrollment\r\n** If archival FFPE tissue is unable to be obtained or is insufficient, patients will be required to undergo biopsy of a metastatic site if feasible for determination of FA/BRCA signature status.
Formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival) - Biopsy should be excisional, incisional, or core. Needle aspiration is insufficient.
Participants must have sufficient tissue from most recent surgery revealing glioblastoma or variants for submission following registration. The following amount of tissue is required:\r\n* formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) OR\r\n* FFPE unstained slides ( um thick)
Availability of tumor tissue (e.g. formalin-fixed, paraffin-embedded [FFPE]) for genomic profile (typically unstained FFPE - micron slides, minimum of )
Patients must agree to submission of tumor tissue from transurethral resection of the bladder tumor (TURBT) including a paraffin block or formalin-fixed paraffin embedded (FFPE) slides of - microns in thickness; patients must also agree to submission of tissue from cystectomy
Tumor tissue available from original diagnosis and/or recurrence; a minimum of FFPE archival tumor tissue block (preferred) or a minimum of FFPE unstained slides from initial and/or most recent pre-registration biopsy or resection. It is recommended that at least cm^ of tissue composed primarily (defined as greater than %) of tumor is present.
Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: ) the biopsy or resection was performed within year of randomization AND ) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, unstained slides ( minimum) will be acceptable
Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be providedas per documented regulations unstained slides ( minimum) will be acceptable
Provision of tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion\r\n* Tumor tissue may be from a diagnostic biopsy or a portion of a surgical specimen, if surgery is a component of definitive intent therapy\r\n* Formalin fixed paraffin embedded (FFPE) tissue samples are acceptable; a fine needle aspirate, frozen sample, plastic embedded sample, cell block, clot, bone, bone marrow or cytologic specimen will not be acceptable for immunohistochemistry (IHC) analysis\r\n* It is recommended that FFPE blocks be sectioned fresh (within days of sectioning and sending for PD-L analysis) onto positively charged slides; slides should be stored and shipped (and stored upon receipt at Qualtek) at - Celsius (C) in the dark\r\n* Recommended fixation time for samples is hours to hours in % neutral buffered formalin
Sufficient archival tissue available for correlative studies; submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue from a previous biopsy or resection is required, and the most recent specimen is preferred; if a FFPE block cannot be provided, then unstained, positively-charged slides of - um thickness must be submitted; if insufficient archival tissue is available, a repeat biopsy will be necessary
Confirmation of availability of sufficient tissue from a prior surgery for correlative studies is required prior to enrollment; these samples must be sent to the DFCI Coordinating Center within days of registration; Cohort participants must have sufficient formalin fixed paraffin embedded (FFPE) tissue from any surgery; Cohort participants must have tissue from biopsy or resection from the most recent recurrence surgery; the following amount of tissue is required:\r\n* unstained formalin fixed paraffin embedded (FFPE) sections (standard - micrometer thickness)\r\n* AND H&E stained slide (or additional unstained - um slide for staining) \r\n* AND one of the following for genomics/nucleic acid extraction:\r\n** At least (preferably ) unstained FFPE sections of micrometer thickness OR\r\n** At least tissue cores from an FFPE block ( micrometer total thickness of tissue from a block with a total surface area of . cm^) OR\r\n** At least mg of frozen tissue
Whenever possible, a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) for biomarker evaluation should be made available and submitted to the central lab for correlative studies
Fresh/archived tumor tissue available for molecular marker testing is required for entry; a tumor block or at least unstained slides must be available; as an alternative formalin-fixed paraffin-embedded (FFPE) cell block that is sufficient for histologic analysis is acceptable
Archival tumor biospecimen (when available) must be procured for correlative evaluation; if tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study\r\n* Formalin fixed, paraffin embedded (FFPE) tissue block(s) or at least unbaked, unstained slides are required; tissue samples taken from a metastatic lesion prior to the start of screening are acceptable
Subjects must provide sample of archival tumor tissue (tissue block preferred, at least formalin-fixated, paraffin-embedded [FFPE] slides acceptable) collected any time before the general screening; a fresh biopsy will be collected if archival sample is unavailable or insufficient
Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of slides
Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of ( preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for PIKCA-mutation testing
Have an archived tissue sample to be submitted either as a formalin fixed paraffin-embedded (FFPE) tumor block, or to unstained slides
Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: ) the biopsy or resection was performed within year of enrollment AND ) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and enrollment onto the current study. If an FFPE tissue block cannot be provided as per documented regulations,, unstained slides ( minimum) will be acceptable.
Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided, unstained slides ( minimum) will be acceptable
Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone metastases samples are not acceptable for submission)
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient
Either a formalin fixed tissue block or a minimum of slides of tumor sample (archived or fresh) must be available for biomarker evaluation (a local pathologist must review for adequacy of sampling)
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides to demonstrate HER expression.
Availability of archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] tissue block or - unstained slides)
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or minimum of unstained slides of tumor sample obtained via excisional, incisional, or core needle biopsy from a metastatic or loco-regionally recurrent lesion; a new baseline biopsy does not need to be obtained for study purposes; if unstained are unavailable from a metastatic or loco-regionally recurrent lesion, with permission of the principal investigator (PI), FFPE tumor tissue from the primary disease site at the time of original diagnosis is acceptable
Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis:
Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample
Participants should be able to submit unstained formalin-fixed, paraffin-embedded (FFPE) slides from the initial tissue diagnosis prior to study registration for confirmation of diagnosis and correlative studies