Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Patients and Healthy Participants Undergoing Colonoscopy, Endoscopy, or Surgery
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ClinicalTrials.gov Identifier: NCT00899626 |
Recruitment Status
: Unknown
Verified January 2013 by Nipun B. Merchant, Vanderbilt University.
Recruitment status was: Recruiting
First Posted
: May 12, 2009
Last Update Posted
: January 23, 2013
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures |
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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. |
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Detailed Description | OBJECTIVES:
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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Blood, Tissue, Body Fluids |
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Sampling Method | Probability Sample | |||
Study Population | Patients with GI malignancy | |||
Condition |
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Intervention |
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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. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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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 |
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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 |
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PRS Account | Vanderbilt University | |||
Verification Date | January 2013 |