Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery
Conditions
Colorectal Cancer - Esophageal Cancer - Gastric Cancer - Pancreatic Cancer - Precancerous Condition
Conditions: official terms
Esophageal Neoplasms - Pancreatic Neoplasms - Precancerous Conditions - Stomach Neoplasms
Conditions: Keywords
colon cancer, esophageal cancer, gastric cancer, pancreatic cancer, adenomatous polyp
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Intervention
Name: protein analysis Type: Genetic
Name: proteomic profiling Type: Genetic
Name: biologic sample preservation procedure Type: Other
Name: laboratory biomarker analysis Type: Other
Name: medical chart review Type: Other
Name: diagnostic colonoscopy Type: Procedure
Name: diagnostic endoscopic procedure Type: Procedure
Name: diagnostic endoscopic surgery Type: Procedure
Name: diagnostic surgical procedure Type: Procedure
Name: endoscopic surgery Type: Procedure
Name: screening colonoscopy Type: Procedure
Overall Status
Recruiting
Summary
RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy participants 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 healthy 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 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- 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

- Healthy volunteer

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

PATIENT CHARACTERISTICS:

- Hemoglobin ≥ 8.0 g/dL

- Not pregnant

- Fertile participants must use effective contraception

- Capable of giving informed consent

- Not mentally or medically impaired

- No bleeding disorder

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
Locations
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center - 800-811-8480
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Status: Recruiting
Contact: Nipun B Merchant - 615-322-2391
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Status: Recruiting
Contact: Nipun B Merchant - 615-322-2391
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States
Status: Recruiting
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas - 615-327-4751
Start Date
June 2002
Sponsors
Vanderbilt University
Source
Vanderbilt University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page