Status:
COMPLETED
NSABP Patient Registry and Biospecimen Profiling Repository
Lead Sponsor:
NSABP Foundation Inc
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a study to collect and analyze tissue specimens from metastatic colorectal cancer (mCRC) patients for the development of a molecularly profiled tissue repository for the primary purpose of mai...
Detailed Description
Tissue blocks from the primary tumor site and an uninvolved margin of resection (normal tissue) from consenting patients will be submitted and stored at the NSABP Division of Pathology, in the NSABP B...
Eligibility Criteria
Inclusion
- The patient must have a diagnosis of metastatic colorectal adenocarcinoma.
- Representative formalin-fixed paraffin-embedded (FFPE) tissue blocks from the primary colorectal tumor surgery with corresponding pathology report must be available for release by the local pathology department (an adequate amount of tumor tissue is required for analysis). If available for release, a separate FFPE tissue block from an uninvolved margin of colorectal resection (normal tissue) is also requested.
- The patient must have a life-expectancy of greater than or equal to 6 months.
Exclusion
- History of non-CRC malignancy unless the patient is considered by the physician to be disease-free and at low risk for recurrence.
- Known comorbid medical conditions that would preclude investigational treatment (e.g., active hepatitis B or C; symptomatic cardiac disease; renal insufficiency; bone marrow impairment).
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude investigational treatment.
- Colonoscopy biopsies or diagnostic core biopsy procedures without surgery or resection.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
3232 Patients enrolled
Trial Details
Trial ID
NCT01793805
Start Date
February 1 2013
End Date
March 1 2022
Last Update
March 31 2022
Active Locations (46)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
Kaiser Permanente-San Diego
San Diego, California, United States, 92120
3
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
4
University of Florida
Gainesville, Florida, United States, 32610