Protocol Summary

Protocol No.: OCR12704

Sponsor Protocol No.: MPR-1

Protocol Title: NSABP Patient Registry and Biospecimen Profiling Repository

Principal Investigator: George, Thomas

Objective: 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.

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 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.

Phase: Phase IV

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: National

Treatment:
This is not a treatment study. There is no therapy involved.

Detailed Eligibility:
INCLUSION CRITERIA:
1. Ages 18 years-old and older.
2. The patient must have a diagnosis of metastatic colorectal adenocarcinoma.
3. 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.
4. The patient must have a life-expectancy of greater than or equal to 6 months.
EXCLUSION CRITERIA:
1. History of non-CRC malignancy unless the patient is considered by the physician to be disease-free and at low risk for recurrence.
2. Known comorbid medical conditions that would preclude investigational treatment (e.g., active hepatitis B or C; symptomatic cardiac disease; renal insufficiency; bone marrow impairment).
3. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude investigational treatment.
4. Colonoscopy biopsies or diagnostic core biopsy procedures without surgery or resection.

Applicable Conditions:

  • Colon Cancer
  • Participation Institution:

  • UF Gainesville : Margaret Veal
  • Contact:
    Margaret Veal
    Phone: +1 352-265-0680 ext. 87656
    Email: mamcewan@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT01793805