NSABP Patient Registry and Biospecimen Profiling Repository (MPR-1)

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.

Inclusion criteria:

• Ages 18 years old and older.
• 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 criteria:

• 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.