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

Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00899626

Enrollment

5000

Registered

2009-05-12

Start date

2002-06-01

Completion date

2045-10-01

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Precancerous Condition

Keywords

colon cancer, gastric cancer, pancreatic cancer, esophageal cancer, adenomatous polyp

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients undergoing colonoscopy, endoscopy, or surgery	Through study completion, approximately 30 years	Genomic and proteomic biomarkers
Development of new screening strategies based on substances found in tissue and biofluid samples	Through study completion, approximately 30 years	Genomic and proteomic biomarker discovery

Countries

United States

Contacts

CONTACTKristen K Ciombor, MD

kristen.k.ciombor@vumc.org6159368422

CONTACTKeeli B Lewis, BS

keeli.b.lewis@vumc.org

Outcome results