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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nipun B. Merchant, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00899626
First received: May 9, 2009
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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 ] [ Designated as safety issue: No ]
  • Development of new screening strategies based on substances found in tissue and biofluid samples [ Time Frame: Indefinately ] [ Designated as safety issue: No ]

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with GI malignancy

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
  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 ClinicalTrials.gov identifier: NCT00899626

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Nipun B Merchant    615-322-2391      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Nipun B Merchant    615-322-2391      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Veterans Affairs Medical Center - Nashville Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas    615-327-4751      
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Chair: Nipun B. Merchant Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Nipun B. Merchant, Professor of Surgery and Cancer Biology, Vanderbilt University
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014