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Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients
NCT00899626 · Vanderbilt University Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids
About this study
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.
Eligibility 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
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2002-06
Estimated completion: 2045-10
Last updated: 2026-03-05
Primary outcomes
- • 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)
- • Development of new screening strategies based on substances found in tissue and biofluid samples (Through study completion, approximately 30 years)
Sponsor
Vanderbilt University Medical Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactKristen K Ciombor, MD · contact · kristen.k.ciombor@vumc.org · 6159368422
ContactKeeli B Lewis, BS · contact · keeli.b.lewis@vumc.org
All locations (2)
Veterans Affairs Medical Center - NashvilleRecruiting
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States