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NCT00399607 · ClinicalTrials.gov registry record
Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention
A clinical trial of Colorectal Adenomatous Polyps, sponsored by Emory University.
- Completed
- Registry status
- 264
- Enrollment target
- 9
- Study locations
NCT00399607: Completed study of Colorectal Adenomatous Polyps, sponsored by Emory University.
NCT00399607 is a study of Colorectal Adenomatous Polyps that has completed, run by Emory University. The registered enrollment target is 264 participants. The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00399607, a study of Colorectal Adenomatous Polyps, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 264 participants
- Enrollment target
- 9
- Study locations
Study Summary
The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colon growths, called adenomatous polyps, which are known to be precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who will get new colon polyps or not.
Primary Outcome
Cyclo-oxygenase-2 (COX-2) is an enzyme that is elevated during periods of inflammation. Inflammation and inflammation regulation likely have important roles in colon cancer development. Control of inflammatory response suppresses COX-2.
Conditions Studied
Interventions
- PROCEDURE Rectal biopsy during colonoscopy
- PROCEDURE Rectal biopsy at randomization
- PROCEDURE Rectal biopsy at 1 year
- PROCEDURE Rectal biopsy prior to colonoscopy
- PROCEDURE Biopsies during colonoscopy
Study Locations (9)
California
- USC/Norris Comprehensice Cancer Center - Los Angeles
Colorado
- University of Colorado Health Sciences Center - Denver
Georgia
- Emory University - Atlanta
Iowa
- University of Iowa Hospitals & Clinic - Iowa City
Minnesota
- University of Minnesota - Minneapolis
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2006-06 |
| Est. Completion | 2016-08 |
What the finished NCT00399607 record still lists
NCT00399607 is an observational study that tracks outcomes without assigning an intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Colorectal Adenomatous Polyps appearing as the primary indexed condition, and to 5 interventions - of which Rectal biopsy during colonoscopy is the first listed.
NCT00399607 lists 9 locations in 9 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT00399607 about?
NCT00399607 is a clinical study titled "Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention". The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colo...
What is the current status of trial NCT00399607?
This trial is currently completed. The enrollment target is 264 participants. The study started on 2006-06. Estimated completion is 2016-08.
What conditions does trial NCT00399607 study?
This clinical trial studies the following conditions: Colorectal Adenomatous Polyps.
What interventions are being tested in trial NCT00399607?
The interventions under investigation include: Rectal biopsy during colonoscopy (PROCEDURE), Rectal biopsy at randomization (PROCEDURE), Rectal biopsy at 1 year (PROCEDURE), Rectal biopsy prior to colonoscopy (PROCEDURE), Biopsies during colonoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT00399607?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00399607 being conducted?
This trial has 9 study locations across California, Colorado, Georgia, Iowa, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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