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

Tracking Information
First Submitted Date	May 9, 2009
First Posted Date	May 12, 2009
Last Update Posted Date	January 23, 2013
Study Start Date	June 2002
Estimated Primary Completion Date	June 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 21, 2013)	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 ]
Original Primary Outcome Measures; (submitted: May 9, 2009)	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; Development of new screening strategies based on substances found in tissue and biofluid samples
Change History	Complete list of historical versions of study NCT00899626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery
Official Title	Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids
Brief Summary	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.
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.
Study Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Blood, Tissue, Body Fluids
Sampling Method	Probability Sample
Study Population	Patients with GI malignancy
Condition	Colorectal Cancer; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Precancerous Condition
Intervention	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 Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: May 9, 2009)	1000
Original Estimated Enrollment	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	June 2016 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00899626
Other Study ID Numbers	CDR0000584214; P30CA068485 ( U.S. NIH Grant/Contract ); VU-VICC-GI-0283; VU-VICC-010680
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Nipun B. Merchant, Vanderbilt University
Study Sponsor	Vanderbilt University
Collaborators	National Cancer Institute (NCI)
Investigators	Study Chair: Nipun B. Merchant Vanderbilt-Ingram Cancer Center
PRS Account	Vanderbilt University
Verification Date	January 2013