[c09aa8]: / clusters / 9knumclustersv2 / clust_2049.txt

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Patients must have pre-treatment blood and tissue specimens submitted for translational medicine as outlined; with patient consent, residuals will be banked for future research
Patients must have specimens submitted for FLT testing for randomization stratification; collection of pretreatment specimens must be completed within day of registration to Step ; specimens must be submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System; FLT results will be used for stratification purposes at the time of randomization; E-mail notification of randomization assignment must be received prior to Step registration
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
Patient must be willing to have tissue specimens submitted for translational medicine studies
Patients must have specimens submitted for blinatumomab immunogenicity assessment; collection of pretreatment specimens must be completed within days prior to registration to S; specimens must be submitted to LabConnect
Patients must agree to have specimens submitted for blinatumomab immunogenicity testing if subsequently moved to a blinatumomab containing treatment regimen on protocol
Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
Willingness to provide mandatory tumor tissue specimens for correlative research
Willingness to provide mandatory tumor tissue and/or blood specimens for correlative research
Confirmed availability of representative tumor specimens
Availability of diagnostic tumor tissue specimens for correlative studies
A pretreatment research core biopsy of the primary tumor must be performed with submission of cores for required correlative studies. These specimens will NOT be returned to the site.
Willingness to provide all biologic specimens as required by the protocol
Patients must be willing to have archived tumor specimens utilized for correlative studies if available
Willingness to provide mandatory biological specimens for research purposes
Willing to provide mandatory biological specimens for research purposes
Either enrolled in Human Research Protection Office (HRPO)# (Tissue and blood acquisition for genomic analysis and collection of health information for patients with gastrointestinal cancers), which facilitates the collection of specimens for correlative studies, or consenting to collection of blood and tissue as part of this protocol for research testing
Willing to provide all biologic specimens as required by the protocol
Willingness to provide mandatory blood specimens for correlative research
Willingness to provide mandatory tissue specimens for correlative research
Availability of tumor specimens is mandatory for patients in the confirmation phase;
Willingness to provide mandatory blood specimens and bone marrow specimens for correlative research
Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing
Patient must agree to provide fresh biopsy specimens and peripheral blood samples at the time of screening and during the study
ARM A: Willingness to provide all biological specimens as required by the protocol
ARM B: Willingness to provide all biological specimens as required by the protocol
Willingness to provide the biologic specimens
Cohort II (MTD): willing to provide the biologic specimens as required by the protocol; note: this is part of the mandatory translational research component; note: patients with the only tumor accessible for biopsy in the pancreas will not be eligible as core biopsies are associated with significant increase in risk for the patient
Willing to provide biologic specimens as required by the protocol
Willing to provide consent to Institutional Review Board (IRB) number (#) - and provide research tissue and blood specimens
Patients must agree to have blood specimens submitted for pharmacokinetic analysis
Patient must have archived primary tumor biopsies or surgical specimens, or biopsies of recurrent or metastatic samples
Sites must seek additional patient consent for the future use of specimens
Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within days prior to registration to S; specimens must be submitted to the sites preferred cytogenetics laboratory
Patients must be offered participation in banking of specimens for future research; with the patients consent, specimens (serum and bone marrow biopsy core) must be submitted to the repository; patient consent must be obtained before specimens are submitted
Biopsies (DLBLC, MM): Diagnostic archival FFPE (either in tumor blocks or sectioned/mounted specimens) may be submitted in lieu of a pre-study research biopsy if it has been obtained no more than year prior to enrollment and only after discussion with the Celgene Medical Monitor
Willingness to provide the biologic specimens and participate in imaging studies as required by the protocol
Representative tumor specimens as specified by the protocol
Lack of archival specimens from the time of primary or recurrence diagnosis
Representative tumor specimens as specified by the protocol
Willing to provide all biological specimens as required by the protocol for correlative research purposes
Unwilling to provide consent for genetic studies of tumor, whole blood, or plasma specimens
Willingness to provide all biological specimens as required by the protocol
>= positive cores within diagnostic biopsy specimens
Consent to provide archived tumor specimens
Willingness to provide the blood specimens as required by the protocol; please note that the willingness to participate pertains only to the patient and does not factor in the institutions ability to participate in any part of the translational component
Patients must have peripheral blood and bone marrow aspirate specimens obtained within days prior to registration submitted for translational medicine; with patient consent, residuals will be banked for future research
Patients must have provided informed consent, be willing to have blood specimens taken, and exhibit no severe other medical or psychiatric problems
Specimens for cytogenetic analysis are required, and must be obtained prior to therapy initiation; for patient with refractory disease, the diagnostic specimen may be used
Patients must be willing to submit blood specimens
Sites must seek additional patient consent for the future use of specimens
Patients must be willing to submit blood and tissue specimens for translational medicine
Willing to provide mandatory blood and urine specimens for correlative research; NOTE: can be waived with permission of study chair (documentation such as an email must be provided)
Patients participating through PK sites, must be offered the option to submit blood specimens for population pharmacokinetic analysis
Willingness to provide mandatory blood specimens
Bone marrow and/or peripheral blood specimens will be submitted for correlative studies; patients who have a dry tap will still be eligible