NSABP Patient Registry and Biospecimen Profiling Repository

Completed

Conditions studied: Colorectal Cancer

In brief

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 maintaining a patient registry for future clinical trials based on the molecular profile of the tumors. The main purpose of testing these tissue specimens is to identify genetic alterations or biomarkers associated with colorectal cancer such that if new agent(s) become available, particularly those that target these genetic alterations/biomarkers, participants may be offered the opportunity to take part in a National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.

Key facts

Study ID

NCT01793805

Run by

NSABP Foundation Inc

People needed

3232

Starts

2013-02-01

Expected to finish

2022-03-01

Last updated by the study team

2022-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Kaiser Permanente-San Diego — San Diego, California, United States
• Kaiser Permanente-Vallejo — Vallejo, California, United States
• University of Florida — Gainesville, Florida, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• St. Luke's Mountain States Tumor Institute - Boise — Boise, Idaho, United States
• Kootenai Health Cancer Services — Post Falls, Idaho, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Medstar Franklin Square Medical Center, Weinberg Cancer Institute — Baltimore, Maryland, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Michigan State University — East Lansing, Michigan, United States
• Cancer Research Consortium of West Michigan — Grand Rapids, Michigan, United States
• CCOP, Kalamazoo, MI — Kalamazoo, Michigan, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• CCOP - Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• Randolph Hospital — Asheboro, North Carolina, United States
• Mission Hospitals — Asheville, North Carolina, United States
• Carolinas Medical Center/Levine Cancer Center — Charlotte, North Carolina, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.