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

Last updated: March 2, 2026
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Disorders

Precancerous Condition

Esophageal Cancer

Treatment

diagnostic endoscopic procedure

laboratory biomarker analysis

medical chart review

Clinical Study ID

NCT00899626
CDR0000584214
VU-VICC-010680
P30CA068485
VU-VICC-GI-0283
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 5000
Treatment Group(s): 11
Primary Treatment: diagnostic endoscopic procedure
Phase:
Study Start date:
June 01, 2002
Estimated Completion Date:
October 31, 2045

Study 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.

Connect with a study center

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232-6838
    United States

    Active - Recruiting

  • Vanderbilt-Ingram Cancer Center - Cool Springs

    Nashville, Tennessee 37064
    United States

    Active - Recruiting

  • Vanderbilt-Ingram Cancer Center at Franklin

    Nashville, Tennessee 37064
    United States

    Active - Recruiting

  • Veterans Affairs Medical Center - Nashville

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

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