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

May 9, 2009
January 21, 2013
June 2002
June 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 [ Designated as safety issue: No ]
  • Development of new screening strategies based on substances found in tissue and biofluid samples [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899626 on ClinicalTrials.gov Archive Site
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Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery
Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood, Tissue, Body Fluids

Probability Sample

Patients with GI malignancy

  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
United States
 
NCT00899626
CDR0000584214, P30CA068485, VU-VICC-GI-0283, VU-VICC-010680
Yes
Nipun B. Merchant, Vanderbilt University
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: Nipun B. Merchant Vanderbilt-Ingram Cancer Center
Vanderbilt University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP