Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 7 | 11 | 6 | ||
| 2 | 8 | specimen | 5 | of tumor tissue is required for all patients investigators shomcLd check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial | 2 |
| 3 | 14 | patients must be offered participation in specimen | 2 | criteria | 2 |
| 4 | 23 | patient must have adequate tumor specimen available for | 2 | to the sponsor prior to study treatment . | 1 |
| 5 | 1 | tumor tissue samples must be available for | 1 | for her 2 testing her 2 testing must be completed by the central lab prior to step 2 randomization | 1 |
| 6 | 2 | patients must have tumor slides available for | 1 | of tissue and blood for future research | 1 |
| 7 | 3 | patients must be given the opportunity to consent to the optional | 1 | is mandatory prior to registration as resmcLts will be used for stratification | 1 |
| 8 | 4 | 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 | 1 | was evaluable for pd l1 status | 1 |
| 9 | 5 | registration step 1 specimen | 1 | patients must have sufficient tissue available for the required biology study | 1 |
| 10 | 6 | 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 | 1 | will be banked for future research | 1 |
| 11 | 9 | 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 | 1 | of pre treatment serum tumor tissue and whole blood is required | 1 |
| 12 | 10 | patients must have adequate tumor tissue to meet the minimum requirement for | 1 | it shomcLd be initiated as soon after surgery as possible | 1 |
| 13 | 11 | enrolling institutions are reminded that | 1 | failure to submit these materials will make the patient ineligible for this study | 1 |
| 14 | 12 | 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 | 1 | for future research with patient s consent specimens must be submitted as outlined | 1 |
| 15 | 13 | 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 | 1 | of original biopsy for review and verification by hematopathologist at local institution | 1 |
| 16 | 16 | patients must have archived tumor tissue from prior tumor biopsy or surgical resections available for | 1 | that is sufficient to complete molecmcLar profiling | 1 |
| 17 | 17 | patients must have 10 representative hematoxylin and eosin h e stained thyroid tissue slides or tumor block available for | 1 | to central pathology review this review is mandatory prior to registration to confirm eligibility | 1 |
| 18 | 19 | baseline skin biopsy taken within 6 months available for central review | 1 | of research blood draw and / or tumor sample | 1 |
| 19 | 20 | patients must agree to biospecimen | 1 | for tissue and serum processing and storage for secondary biomarker studies | 1 |
| 20 | 21 | participant must have archived tumor tissue available from initial diagnosis or subsequent relapse s of grade iv gbm for | 1 | for central review at investigational sites local laboratories . | 1 |
| 21 | 24 | ct imaging review | 1 | of tumor samples from the diagnostic biopsy and breast surgery is required for all patients | 1 |
| 22 | 30 | patients must have tumor tissue available for | 1 | to confirm unilateral pleural involvement this review for ct imaging is mandatory prior to registration to confirm eligibility it shomcLd be initiated as soon as possible after pre registration | 1 |
| 23 | 35 | patient must have sufficient tumor tissue available for | 1 | 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 shomcLd not be approached for participation in the b 52 trial | 1 |
| 24 | 37 | patients must have paraffin embedded tumor specimen available for | 1 | for translational medicine studies and banking with patient consent specimens must be submitted | 1 |
| 25 | 38 | patient must have archival tumor specimen available for | 1 | criteria patients must be offered optional participation in banking of specimens for future research | 1 |
| 26 | 40 | tumor tissue must be available for | 1 | to assess gene expression of ercc1 and xrcc1 patients must also be offered participation in banking for future use of specimens | 1 |
| 27 | 42 | patients must be offered the option to participate in | 1 | of original biopsy for review by hematopathologist at local institution | 1 |
| 28 | 15 | NA | of copies of tumor measurements and scans | 1 | |
| 29 | 18 | NA | . | 1 | |
| 30 | 22 | NA | 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 | 1 | |
| 31 | 25 | NA | 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 | 1 | |
| 32 | 26 | NA | of original biopsy for review and verification by participating center hematopathologist | 1 | |
| 33 | 27 | NA | for central pathology review | 1 | |
| 34 | 28 | NA | and substudy criteria | 1 | |
| 35 | 29 | NA | of specimens for banking for future translational medicine studies | 1 | |
| 36 | 31 | NA | 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 shomcLd contain the highest grade of tumor or a recommended minimum of 20 unstained serial sections fine needle aspiration | 1 |