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Trial Title:
Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients
NCT ID:
NCT00899626
Condition:
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Precancerous Condition
Conditions: Official terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Precancerous Conditions
Conditions: Keywords:
colon cancer
gastric cancer
pancreatic cancer
esophageal cancer
adenomatous polyp
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
protein analysis
Intervention type:
Genetic
Intervention name:
proteomic profiling
Intervention type:
Other
Intervention name:
biologic sample preservation procedure
Intervention type:
Other
Intervention name:
laboratory biomarker analysis
Intervention type:
Other
Intervention name:
medical chart review
Intervention type:
Procedure
Intervention name:
diagnostic colonoscopy
Intervention type:
Procedure
Intervention name:
diagnostic endoscopic procedure
Intervention type:
Procedure
Intervention name:
diagnostic endoscopic surgery
Intervention type:
Procedure
Intervention name:
diagnostic surgical procedure
Intervention type:
Procedure
Intervention name:
endoscopic surgery
Intervention type:
Procedure
Intervention name:
screening colonoscopy
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.
Criteria for eligibility:
Study pop:
Patients with GI malignancy
Sampling method:
Probability Sample
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
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Veterans Affairs Medical Center - Nashville
Address:
City:
Nashville
Zip:
37212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - Veterans Affairs Medical Center - Nas
Phone:
615-327-4751
Facility:
Name:
Vanderbilt-Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232-6838
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Phone:
800-811-8480
Start date:
June 2002
Completion date:
October 2030
Lead sponsor:
Agency:
Vanderbilt University Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Vanderbilt University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00899626
