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Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Vanderbilt University.
Recruitment status was:  Recruiting
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nipun B. Merchant, Vanderbilt University Identifier:
First received: May 9, 2009
Last updated: January 21, 2013
Last verified: January 2013

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.

Condition Intervention
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Precancerous Condition
Genetic: protein analysis
Genetic: proteomic profiling
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
Other: medical chart review
Procedure: diagnostic colonoscopy
Procedure: diagnostic endoscopic procedure
Procedure: diagnostic endoscopic surgery
Procedure: diagnostic surgical procedure
Procedure: endoscopic surgery
Procedure: screening colonoscopy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Identification of new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and healthy volunteers undergoing colonoscopy, endoscopy, or surgery [ Time Frame: Indefinately ]
  • Development of new screening strategies based on substances found in tissue and biofluid samples [ Time Frame: Indefinately ]

Biospecimen Retention:   Samples With DNA
Blood, Tissue, Body Fluids

Estimated Enrollment: 1000
Study Start Date: June 2002
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with GI malignancy


  • 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


  • 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


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00899626

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: Nipun B. Merchant Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Nipun B. Merchant, Professor of Surgery and Cancer Biology, Vanderbilt University Identifier: NCT00899626     History of Changes
Other Study ID Numbers: CDR0000584214  P30CA068485  VU-VICC-GI-0283  VU-VICC-010680 
Study First Received: May 9, 2009
Last Updated: January 21, 2013

Keywords provided by Vanderbilt University:
colon cancer
esophageal cancer
gastric cancer
pancreatic cancer
adenomatous polyp

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases processed this record on February 20, 2017