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Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
First Received: May 9, 2009   Last Updated: August 11, 2009   History of Changes
Sponsored by: Vanderbilt-Ingram Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00899626
  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/Nonmalignant 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
Official Title: Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

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
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
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-Ingram Cancer Center
Investigators
Study Chair: Nipun B. Merchant Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000584214, VU-VICC-GI-0283, VU-VICC-010680
Study First Received: May 9, 2009
Last Updated: August 11, 2009
ClinicalTrials.gov Identifier: NCT00899626     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
esophageal cancer
gastric cancer
pancreatic cancer
colon cancer
esophageal cancer
gastric cancer
pancreatic cancer
adenomatous polyp

Study placed in the following topic categories:
Precancerous Conditions
Gastrointestinal Diseases
Pancreatic Neoplasms
Esophageal Neoplasms
Colonic Diseases
Polyps
Healthy
Rectal Diseases
Stomach Diseases
Stomach Neoplasms
Adenomatous Polyps
Endocrine Gland Neoplasms
Digestive System Neoplasms
Endocrine System Diseases
Esophageal Cancer
Intestinal Diseases
Intestinal Neoplasms
Digestive System Diseases
Esophageal Disorder
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Esophageal Diseases
Stomach Cancer
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on September 11, 2009