Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples from Colorectal Cancer Patients

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Gastric Cancer; Esophageal Cancer; Precancerous Condition; Pancreatic Cancer; Colorectal Cancer

Treatments: Other: laboratory biomarker analysis; Procedure: diagnostic colonoscopy; Procedure: diagnostic endoscopic procedure; Procedure: diagnostic surgical procedure; Other: medical chart review; Genetic: protein analysis; Procedure: endoscopic surgery; Procedure: screening colonoscopy; Other: biologic sample preservation procedure; Genetic: proteomic profiling; Procedure: diagnostic endoscopic surgery

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00899626

VU-VICC-010680 (Other Identifier)

CDR0000584214

VU-VICC-GI-0283 (Other Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and participants undergoing colonoscopy, endoscopy, or surgery.

Full description

OBJECTIVES:

• Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and 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 are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center AND

• Meets 1 of the following criteria:

  • Diagnosis of gastrointestinal (GI) cancer, polyps, or inflammatory bowel disease
  • History of previously treated GI cancer, polyps, or inflammatory bowel disease

PATIENT CHARACTERISTICS:

• Capable of giving informed consent
• Not mentally or medically impaired
• No bleeding disorder

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics