NSABP Patient Registry and Biospecimen Profiling Repository

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 Biospecimen Profiling Repository. Tissue specimens will be used to
profile molecular characteristics, including actionable mutations most commonly identified
in colorectal cancer. Specimens may be further interrogated by other methods to discover
additional mechanisms and targetable genetic alterations that may predict sensitivity or
resistance to drug therapies.

The repository will be populated, maintained, and analyzed through continuous patient
recruitment. Patient tumor specimens will be interrogated to characterize an individual's
molecular profile. At a future date for discovery purposes, the normal tissue may be
profiled for comparison with the profile of the tumor tissue. NSABP will hold a database
with molecular profiles and relevant patient information. As agents become available for
clinical study, particularly those matching specified profiles, the treating physician will
be contacted so that the patient may be offered participation in that trial via a separate
consent process. Each NSABP trial will have a defined molecular profile for entry which will
be specific to the agent(s) under study. The MPR-1 patient registry and tissue repository
and all treatment protocols associated with MPR-1 are being developed as part of the NSABP
Oncology-Genome Assessment Guided Medicine (N-GAMe) Program.

This registry and repository platform uses a translational science approach for more
personalized therapy for patients with mCRC. This analysis provides an individual molecular
profile in an attempt to direct each patient's treatment based on the pattern of genetic
alterations. These efforts also may aid in the discovery of with or without new gene targets
for future drug development.

Approximately 1000-2000 tumor (with or without) normal tissue specimens from living mCRC
patients will be collected, stored, and analyzed as part of this biospecimen repository. It
is anticipated that 200-400 participants will be registered within the first year.

Inclusion Criteria:

- 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.