[c09aa8]: / clusters / 9knumclustersv2 / clust_612.txt

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ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP ): Must have PAM analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast resected at the time of definitive surgery completed
Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence\r\n* NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patients disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment
Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
Subjects with ED SCLC must consent to provide available archived formalin fixed paraffin embedded (FFPE) tissue sample of SCLC lesion (primary or metastatic) for central review and biomarker analysis.
Oestrogen receptor, progesterone receptor and HER negative advanced adenocarcinoma of breast. Parts A, B or D (solid malignancies) - Consented provision of formalin fixed paraffin embedded blocks/ slides from most recent tissue sample. Part C (all patients):
Willingness to undergo biopsy; if biopsy is not felt to be possible or safe, permission must be received from Dr. Tung to forgo a biopsy; in that event, formalin fixed, paraffin embedded (FFPE) tumor sample from a prior metastatic biopsy (preferable) or from the primary tumor tissue will be collected, unless none is available and Dr. Tung provides approval; if paraffin blocks are unable to be sent to for analysis due to institutional policy, unstained paraffin slides may be sent instead; a formal eligibility exception is not needed as long as approval is granted and documented by Dr. Tung
Subject has consented to provide archival formalin-fixed, paraffin-embedded (FFPE) tumor block; if archival tissue is not available, Subject must consent to tumor biopsy.
Be willing to allow the use of archival formalin-fixed paraffin-embedded tumor tissue for correlative analyses\r\n* Note: The archived tumor tissue specimens may be from prior surgery or from prior diagnostic biopsy of primary or metastatic tumor specimen; unavailability of archived tissue will not render subject ineligible for study
Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.
Able to provide a fresh formalin-fixed, paraffin-embedded (FFPE) tumor sample for central evaluation of HER status prior to enrolment; if a fresh biopsy is not feasible, sponsor approval is required and archived tumor biopsy must be provided for centralized testing by sponsor
Formalin-fixed paraffin embedded (FFPE) tumor tissue from previous biopsy is requested, but not mandatory
Patients must provide written consent to allow a core needle biopsy samples of tumor tissue (primary or metastatic) to be obtained during baseline for analysis of mutations associated with his/her malignancy, and for correlation studies; if available, patients may elect to provide a formalin fixed paraffin embedded (FFPE) tissue block (from his/her primary or metastatic tumor) obtained within days prior to written consent for the clinical trial granting release of the paraffin block; planned to undergo standard surgical resection for potential cure or for palliation when applicable
Availability of archival formalin-fixed paraffin embedded (FFPE) tumor tissue slides ( of uM thick sections, and of uM thick sections)
Patients must have adequate pre-trial formalin-fixed paraffin-embedded (FFPE) tumor material available for use in the biology studies mutational analysis and genome wide sequencing for each stratum\r\n* Patients with DIPG who have tissue available are requested to submit similar tissue as patients in other strata; however, this is not required for eligibility
Formalin fixed paraffin embedded tumor tissue (preferably from current recurrence) must be available to assess Rb protein status prior to enrollment; only patients with recurrent diffuse intrinsic brain stem glioma (DIPG) can be enrolled without the need for available tumor tissue for Rb protein status confirmation
Willingness to provide paraffin-embedded tissue blocks of ovarian cancer
CD staining is to be performed on fresh biopsy or archival formalin-fixed paraffin-embedded (FFPE) tissue however CD positivity is not required for eligibility
Available archival formalin-fixed paraffin-embedded (FFPE) from a prior biopsy or, participant must be willing to have a tissue biopsy taken at a clinic visit prior to start of study treatment
Patients must agree to submission of tumor blocks or - formalin-fixed paraffin embedded (FFPE) slides of - microns in thickness from transurethral resection of bladder tumor (TURBT) and radical cystectomy tissues
Have sufficient available material from archived formalin-fixed paraffin-embedded tumor tissue for biomarker-related studies. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.
Prostate biopsy. If previous biopsy has been performed within months of screening, second biopsy procedure will not be required, if archival biopsies and at least one formalin fixed paraffin embedded biopsy tissue block containing tumor is available.
The formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be available to be sent for retrospective central pathology review after registration)
At least one prior surgery with available archival formalin-fixed paraffin-embedded (FFPE) tumor blocks
Patient's tissue must be positive for p by immunohistochemical staining (> % staining); fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin fixed paraffin-embedded cell block material is available for p immunohistochemistry
Participant must consent to repeated biopsy to allow the acquisition of fresh and/or formalin-fixed paraffin-embedded (FFPE) material. Available archived tumor material may be submitted as the pretreatment biopsy provided that minimum requirements are met by local pathology review as defined in the laboratory manual. If archived tumor material is not available or does not meet minimum requirements, then a fresh tumor biopsy must be obtained in accordance with local institutional practice.
Confirmed availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue
Pathology review demonstrates tumor cellularity no less than % in quantities sufficient to obtain - mm biopsies from the original formalin-fixed paraffin-embedded (FFPE) blocks
Available representative tissue (- slides from fresh or formalin fixed paraffin embedded tissue) from the most recent biopsy or archival tumor tissue for clonotype evaluation for minimal residual disease (MRD) testing
Archival formalin-fixed paraffin-embedded (FFPE) tumor tissue must be available for correlative studies (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission)
Must give valid written consent to provide archival formalin-fixed paraffin-embedded (FFPE) and/or newly acquired tumor tissue for the purpose of establishing baseline PD-L status as well as consent to provide on- and/or post-treatment tumor biopsy sample
Available archival tumor tissue for correlative studies; submission of archival transrectal ultrasound (TRUS) prostate biopsy tissue is required if available, in the form of representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least slides, with an associated pathology report; if archival prostate tissue are unavailable or cannot be obtained, a repeat TRUS prostate biopsy is not required for eligibility
The patient/legal representative must be willing to provide written consent for collection of formalin fixed paraffin-embedded blocks or slides from archival diagnostic histology samples, where available
The subject must be medically capable of providing the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor\r\n* This requirement may be satisfied by providing an archival tissue sample in the form of a formalin-fixed paraffin-embedded or frozen tissue block from an earlier resection
Subject has one archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue confirmed available for analyses.
Phase b only: Formalin-fixed paraffin embedded blocks (FFPB) or fresh frozen tissue from the original diagnosis or the metastatic setting should be located; tissue must be submitted with weeks of study initiation
Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy;
Available archived tumor (formalin-fixed, paraffin-embedded tissue block) for genomic and proteomic analysis
Provision of an archival tissue block, or formalin-fixed paraffin-embedded (FFPE) slides, if available, and if not available having biopsiable disease and agreeing to pre-treatment biopsies
Availability of an archival (? months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample which has not previously been irradiated
There must be availability of a formalin-fixed, paraffin-embedded tumor specimen
Available core biopsies from the time of diagnosis; these may include sections paraffin-embedded material
Patients must be willing to provide archival formalin-fixed paraffin-embedded (FFPE) or frozen specimens for central analysis, if available
Participant has one of the following available for PD analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle Day .
Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
Subject has measurable disease according to RECIST .. . Archival formalin-fixed, paraffin-embedded tumor sample collected within days prior to subject consent available or subject has biopsiable metastatic lesion and is willing to undergo biopsy .
Willingness and ability to provide archived formalin fixed paraffin embedded tissue block or a partial block from surgery after neoadjuvant chemotherapy and from core-biopsy before start of neoadjuvant chemotherapy, which will be used for centralized retrospective confirmation of hormone- and HER-status and to evaluate correlation between genes, proteins, and mRNAs relevant to the endocrine and cell cycle pathways and sensitivity/resistance to the investigational agents. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.
Availability of formalin-fixed paraffin-embedded tumor tissue diagnostic of glioblastoma.
Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.
Fresh core biopsy, frozen, must be performed before start of therapy and submitted for storage. This is optional only for the subjects who have a biopsy-accessible site and consent to the procedure. In case no prior fixed formalin paraffin embedded (FFPE) biopsy is available, this specimen can also be used for diagnostic confirmation.
Availability of adequate Formalin-fixed, paraffin embedded (FFPE) archival tumor material.
Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.
The formalin-fixed, paraffin-embedded (FFPE) tumor tissue block must be available to be sent for retrospective central pathology review after registration
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
Availability of tumor tissue is required for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin embedded (FFPE) 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 be willing to provide and have available formalin fixed paraffin embedded tissue sample from archival tissue or newly obtained core or excisional biopsy of a tumor lesion for central analysis; Note: fine needle aspirations (FNA), frozen samples, plastic embedded samples, cell blocks, clots, bone, bone marrow, or cytologic specimens are exclusionary
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
Metastatic breast cancer and have formalin-fixed, paraffinembedded primary tumor available for testing BRCA protein expression
Availability of a formalin fixed paraffin embedded (FFPE) block of cancer tissue from the original or most recent biopsy for mutational analysis; availability must be confirmed prior to enrollment
Availability of fresh and archive tumor in formalin fixed paraffin embedded tissue
PART A: Existing formalin fixed paraffin embedded biopsy of the lung cancer with potentially sufficient material for analysis
Ability to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample containing representative tumor tissue from a previously obtained biopsy/resection that meets specific tissue sample requirements at screening
Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
Ability to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample containing representative tumor tissue from a previously obtained biopsy/resection that meets specific tissue sample requirements at screening
Adequate tissue sample from either archival formalin-fixed paraffin-embedded (FFPE) tumor tissue or new biopsy of tumor
Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies is required
Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies required
Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. If there is not written confirmation of the availability of an archived or fresh tumor sample prior to enrollment, the subject is not eligible for the study.
Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of and up to slides of archived tumor tissue for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible
Archival tumor tissue available for immunohistochemistry (IHC) ( paraffin-embedded block)
Availability of a representative formalin fixed paraffin embedded tumor tissue sample. If archival tumor sample is not available, a newly obtained tumor sample needs to be submitted instead.
Representative archival tumor sample from glioblastoma (formalin-fixed paraffine embedded tissue) must be available.
Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy of breast primary tumor
Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-,-bisphosphate -kinase, catalytic subunit alpha (PIKCA) mutation status by central histopathology laboratory
Availability of a representative formalin-fixed paraffin-embedded tumor specimen
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue, either fresh core-needle-biopsied or archived
Patients must have a site of disease that is amenable to pretreatment and on-treatment core biopsies; at least formalin fixed, paraffin embedded (FFPE) slides at five microns each may be collected at each biopsy; determination of tissue accessibility and quantity will be made by the consenting clinician; patients must consent to the two study-required biopsy procedures
Patient must consent to provision of a representative formalin fixed paraffin block of tumor tissue, if available, in order that the specific correlative marker assays may be conducted.
All subjects must provide a tumor tissue sample from [Formalin Fixed Paraffin Embedded (FFPE) slides] archival tissue or fresh biopsy collected before Cycle , Day
Participants with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks (preferred), or sectioned tissue
There must be availability of a formalin-fixed, paraffin-embedded tumor specimen with adequate viable tumor tissue
Local pathology review for histological confirmation; A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
Availability of a formalin fixed paraffin embedded (FFPE) block of cancer tissue from the original surgery or biopsy or from a biopsy of recurrent disease
All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APECSC: Patients must have a formalin fixed paraffin embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto pediatric MATCH for children with diffuse intrinsic pontine gliomas (DIPG, brainstem gliomas)
The availability of formalin-fixed paraffin embedded archival tissue from core biopsy of tumors is recommended for exploratory analysis
Provision of formalin-fixed paraffin embedded tissue sample from primary or metastatic disease
Subjects must have adequate fresh or paraffin embedded tissue
Patient must be able to provide a formalin-fixed and paraffin-embedded (FFPE) tumor tissue specimen prior to treatment. The specimen may have been taken at any time during the course of the disease and may be from the primary tumor or from a metastasis