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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 Nipun B. Merchant, Vanderbilt University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00899626
First Posted: May 12, 2009
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nipun B. Merchant, Vanderbilt University
  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 Nipun B. Merchant, 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:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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      
Veterans Affairs Medical Center - Nashville Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas    615-327-4751      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Nipun B. Merchant Vanderbilt-Ingram Cancer Center
  More Information

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 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0283
VU-VICC-010680
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by Nipun B. Merchant, 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
Neoplasms
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