Angiosarcoma tumor specimen, if available
Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
Patients must have tumor slides available for submission for HER-2 testing; HER-2 testing must be completed by the central lab prior to step 2 randomization
Patients must be given the opportunity to consent to the optional submission of tissue and blood for future research
Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, cystectomy/nephrectomy/ureterectomy, or nephroureterectomy must be available; this specimen submission is mandatory prior to registration as results will be used for stratification
REGISTRATION STEP 1-SPECIMEN SUBMISSION
Patients must be offered participation in specimen banking; with patient consent, pretreatment specimens must be collected and submitted via the SWOG Specimen Tracking System
Patients must not be registered to step 2 until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing; patients must be registered within 7 days of receiving the e-mail notification confirming submission was evaluable for PD-L1 status
Submission of tumor tissue is required for all patients; investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial
Specimen Submission: Patients must have sufficient tissue available for the required biology study
Patients must have blood and tissue specimens collected prior to registration and submitted for translational medicine; note that patients without adequate diagnostic specimens will not be eligible; with patient consent, residuals from the mandatory submission will be banked for future research
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
United States (US) and Canadian sites:\r\n* This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible
Patients must have had all visible tumor resected completely within 60 days prior to registration; CIS disease is not expected to be completely excised; all patients must have tumor tissue from the histologic diagnosis of recurrence available for central pathology review submission; failure to submit these materials will make the patient ineligible for this study
Patients must be offered participation in specimen submission for future research; with patient’s consent, specimens must be submitted as outlined
Submission of original biopsy for review and verification by hematopathologist at local institution
Patients must have archived tumor tissue from prior tumor biopsy or surgical resections available for submission that is sufficient to complete molecular profiling
Patients must have 10 representative hematoxylin and eosin (H&E) stained thyroid tissue slides OR tumor block available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
Submission of research blood draw and/or tumor sample
Baseline skin biopsy taken within 6 months available for central review submission
Patients must have a pre-treatment tumor specimen available for correlative studies, either core needle biopsy or equivalent amount or via excisional specimen (cytology specimen not acceptable for this purpose); if an archival specimen is to be used then no interceding anticancer therapy (systemic therapy or radiation to the biopsied lesion) should have been administered since that specimen was obtained; patients with no available archived specimen must be willing to undergo a pre-treatment tumor biopsy
Patients must agree to biospecimen submission for tissue and serum processing and storage for secondary biomarker studies
Participant must have archived tumor tissue available from initial diagnosis or subsequent relapse(s) of Grade IV GBM for submission for central review at Investigational sites local laboratories.
Submission of tumor samples from the diagnostic biopsy and breast surgery is required for all patients
An archived tumor specimen is available for collection
Patient must have adequate tumor specimen available for submission
CT imaging review submission to confirm unilateral pleural involvement; this review for CT imaging is mandatory prior to registration to confirm eligibility; it should be initiated as soon as possible after pre-registration
Submission of tumor tissue is required for all patients; investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial
Submission of tumor samples is required for all patients; the local pathology department policy regarding release of tumor samples must be considered in the screening process; patients whose tumor samples are located in a pathology department that by policy will not submit any samples for research purposes should not be approached for participation in the B-52 trial
Patients must be offered participation in specimen submission for translational medicine studies and banking; with patient consent, specimens must be submitted
Specimen Submission Criteria:
SPECIMEN SUBMISSION CRITERIA: Patients must be offered optional participation in banking of specimens for future research
Patients must have tumor tissue available for submission to assess gene expression of ERCC1 and XRCC1; patients must also be offered participation in banking for future use of specimens
A representative tumor specimen must be available for molecular testing.
Submission of original biopsy for review by hematopathologist at local institution
Submission of copies of tumor measurements and scans
SPECIMEN SUBMISSION CRITERIA:
Patient must have adequate tumor specimen available for submission
Patient must have sufficient tumor tissue available for submission.
Submission of research blood draw to be stored until after surgical resection of the primary tumor and confirmation of human papilloma virus (HPV) positivity (Mayo Clinic Rochester patients only)
Patients must have paraffin-embedded tumor specimen available for submission for pathological review and determination of 1p/19q deletion status\r\n* NOTE: it is recommended that patients not be pre-registered until the required tumor specimens are on hand and ready for submission; if submission of tissue will be submitted more than 5 working days after pre-registration, immediately notify the Mayo Clinic Cytogenetics Laboratory via email
Patient must have archival tumor specimen available for submission
Submission of original biopsy for review and verification by participating center hematopathologist
Tumor tissue must be available for submission for central pathology review
SPECIMEN SUBMISSION AND SUBSTUDY CRITERIA
Patients must be offered the option to participate in submission of specimens for banking for future translational medicine studies
Willing to undergo core needle or incisional biopsy to obtain fresh tumor tissue specimens
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 4 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression a) Tumor tissue should be of good quality based on total and viable tumor content. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation. b) Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. c) Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable
Confirmed availability of representative archival tumor specimens in paraffin blocks (preferred) or >= 10 unstained slides, with an associated pathology report\r\n* Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, or punch biopsies for cutaneous, subcutaneous, or mucosal lesions\r\n* Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable\r\n* A subject with insufficient or unavailable archival tissue may be eligible, upon discussion with the principal investigator, if the subject is willing to consent to undergo a pretreatment core, punch, or excisional/incisional biopsy sample collection of the tumor
Tissue Parameters: a. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression (tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable). b. Tumor tissue should be of good quality based on total and viable tumor content. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation. c. Patients who do not have tissue specimens meeting eligibility requirements must be willing to undergo a biopsy during the screening period
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 5 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression \r\n* Tumor tissue should be of good quality based on total and viable tumor content; fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable; for core-needle biopsy specimens, at least three cores should be submitted for evaluation\r\n* Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period; acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions\r\n* Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable
Willingness to undergo a biopsy ? 6 weeks of the start of study treatment to obtain formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 15 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression\r\n• Archival tissue is acceptable if obtained within the protocol specified period and if there is no intervening therapy between the tumor biopsy and the initiation of atezolizumab; tumor tissue should be of good quality based on total and viable tumor content; fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable; for core-needle biopsy specimens, at least three cores should be submitted for evaluation\r\n* Patients who do not have tissue specimens meeting eligibility requirements will be required to undergo a biopsy during the screening period; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions\r\n* Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable
Submission of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens from the previous 18 months, if available; if not available, a fresh tumor biopsy prior to treatment initiation is MANDATORY unless determined medically unsafe or not feasible by the site investigator\r\n* The archival specimen must contain adequate viable tumor tissue\r\n* Specimens may consist of a tissue block (preferred and should contain the highest grade of tumor) or a recommended minimum of 20 unstained serial sections; fine-needle aspiration, brushings, cell pellet from pleural effusion, bone marrow aspirate/biopsy are not acceptable\r\n* Distant metastases specimens are preferred but if not available primary nephrectomy specimens are acceptable
Representative tumor tissue specimens (paraffin block preferred)
Patients must have adequate tumor tissue available for PD-L1 testing; adequate tumor tissue is defined as:\r\n* For core-needle biopsy specimens, at least three cores should be submitted for evaluation if feasible; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions; samples collected from fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases without a soft tissue component, and lavage are not acceptable\r\n* For pre-treatment archival tissue, representative urothelial carcinoma formalin-fixed paraffin-embedded (FFPE) tumor specimens (tumor blocks or 30 unstained slides) must be provided; patients with < 30 slides may be enrolled after discussion with the MSK principal investigator\r\n* Primary or metastatic specimens (with the exception of bone because it is not evaluable for PD-L1 expression) may be submitted
Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, requested at any time prior to study entry; only tissue from core needle, punch, or excisional biopsy sample collection will be accepted; fine-needle aspiration, brushing, and lavage samples are not acceptable; for all biopsy types, submitted blocks should have sufficient tissue to generate at least 15 sections, and tissue for which the pathology report specifies that the overall tumor content is low (e.g., “sparse” or “scant”) is not acceptable; tissue from separate time points (such as time of initial diagnosis and time of metastatic diagnosis) or from the multiple metastatic tumors may also be collected for a given patient, on the basis of availability
If archival tissue is either insufficient or unavailable, the patient may still be eligible if the patient can provide at least five unstained, serial slides or is willing to consent to and undergo a pre-treatment core or excisional biopsy sample collection of the tumor; fine-needle aspiration, brushing, and lavage samples are not acceptable
For participants who will undergo serial biopsy in dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter [mm] in diameter amenable to serial biopsy)
If an archived tumor block exists, then either the block or at least 4 unstained slides from the block should be submitted. Tumor tissue should be of good quality based on total and viable tumor content, i.e. at least 50 viable tumor cells and intact tissue architecture. Fine needle aspiration, brushing,and lavage samples are not acceptable. If the block is tissue from a core-needle biopsy, then the block should contain tissue from at least three cores to be sufficient for evaluation.
Patients who do not have existing (archived) tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, or forceps biopsies for endobronchial or nodal lesions. The tissue should be fixed in formalin and embedded on site and sent as a block.
Archival tumor specimens must be submitted prior to enrollment; samples collected from fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage are not acceptable; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions; if archival tissue is being used, representative urothelial carcinoma formalin-fixed paraffin-embedded (FFPE) tumor specimens (tumor blocks or 30 unstained slides) must be provided; patients with < 30 slides may be enrolled after discussion with the principal investigator; primary or metastatic specimens may be submitted
Representative tumor specimens in paraffin blocks (preferred) or at least 10 unstained slides, with an associated pathology report, requested at any time prior to study entry; only tissue from core needle, punch, or excisional biopsy sample collection will be accepted; fine-needle aspiration, brushing, and lavage samples are not acceptable; for all biopsy types, submitted blocks should have sufficient tissue to generate at least 10 sections, and tissue for which the pathology report specifies that the overall tumor content is low (e.g., \sparse\ or \scant\) is not acceptable; if archival tissue is either insufficient or unavailable, the patient will need to consent to and undergo a pre treatment core or excisional biopsy sample collection of the tumor; fine needle aspiration, brushing, and lavage samples are not acceptable; the immediate unavailability of tissue blocks or unstained slides aside from the slides needed for diagnostic confirmation of lung cancer does not exclude patients from this trial; if the patient chooses to not undergo a repeat biopsy aside from biopsy for diagnostic purposes, the patient will still be eligible to enroll on 2014-0722; however, availability of core or excisional biopsy samples must be ascertained prior to enrollment
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
Representative tumor specimens in paraffin blocks (preferred) or at least 10 unstained slides, with an associated pathology report, requested at any time prior to study entry. Tissue from core needle, punch, or excisional biopsy sample collection is preferred but slides from fine needle aspiration, brushing, and lavage samples are acceptable.
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 10 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression\r\n* Tumor tissue should be of good quality based on total and viable tumor content; fine-needle aspiration, brushing, cell pellet from pleural effusion, and lavage samples are not acceptable; for core-needle biopsy specimens, at least three cores should be submitted for evaluation\r\n* Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period; acceptable samples include core-needle biopsies for deep tumor tissue (minimum of three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions