Trial Information

Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

OBJECTIVES:

- Identify new potential biomarkers of increased gastrointestinal cancer risk using
tissue and biofluid samples from patients and healthy volunteers undergoing
colonoscopy, endoscopy, or surgery.

- Develop new screening strategies based on substances found in tissue and biofluid
samples.

OUTLINE: This is a multicenter study.

Patients and healthy volunteers undergo colonoscopy, endoscopy, or surgery. Patients and
healthy volunteers also undergo tissue (e.g., tumor or normal mucosa) and biofluid (e.g.,
blood, urine, cyst fluids or tumor cells, bile and pancreatic juices, and/or stool) sample
collection. Samples are analyzed for tumor markers by proteomic methods and protein
analysis. If candidate biomarkers are identified, samples are stored for future studies
involving these biomarkers. Information, including demographics, personal and family history
of cancer, and prior and current colonoscopy, endoscopy, or surgery results, is collected
from the medical record and stored in the project database.

Patients and healthy volunteers are followed once a year for up to 5 years to determine if
biomarkers have a prognostic significance.