Spots Global Cancer Trial Database for Chemoprevention of Colorectal Adenomas
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We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Chemoprevention of Colorectal Adenomas
Official Title: A Clinical Trial Evaluating the Efficacy and Safety of a Combination Treatment Administered Over 3 Years in Patients at Risk of Experiencing Recurrence of Colorectal Adenomas
Study ID: NCT00486512
Conditions
Study Description
Brief Summary: The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas.
Detailed Description: This is a multicenter, randomized, parallel group, prospective, double blind, placebo controlled clinical trial of chemoprevention in patients at increased risk of developing colorectal cancer (CRC). The Colotech combination treatment (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) will be compared to placebo with regards to safety and efficacy during 3 years of treatment. The randomized treatment period will be preceded by a 3-week single blind placebo run-in period, which will assess patient's compliance to treatment. In order to collect data on the durability of treatment effect, follow-up data from a surveillance colonoscopy will be collected two years after the 3-year colonoscopy.
Keywords
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Digestive Disorders Center, P.C., Huntsville, Alabama, United States
San Diego Digestive Disease Consultants, Inc., San Diego, California, United States
Advance Digestive Care, Clearwater, Florida, United States
Internal Medicine Specialists, Orlando, Florida, United States
Atlanta Center for Gastroenterology, PC, Decatur, Georgia, United States
Central Indiana Gastroenterology Group, Anderson, Indiana, United States
Gastrointestinal Clinic of Quad Cities, Davenport, Iowa, United States
University of Kentucky Medical Center, Lexington, Kentucky, United States
Gastroenterology Associates of Eastern Maine, Bangor, Maine, United States
Digestive Disorders Associates, Annapolis, Maryland, United States
Office of Alan A. Rosen, M.D., Baltimore, Maryland, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Colon and Rectal Surgery Associates, Ltd., Saint Paul, Minnesota, United States
Digestive Health Specialists, PA, Tupelo, Mississippi, United States
Gastroenterology Research Associates, Cedar Knolls, New Jersey, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Wilmington Gastroenterology Associates, Wilmington, North Carolina, United States
Digestive Health Specialists PA, Winston-Salem, North Carolina, United States
Northwest Gastroenterology Clinic, Portland, Oregon, United States
Regional Gastroenterology Associates of Lancaster, Ltd, Lancaster, Pennsylvania, United States
North Texas Gastroenterology Consultants, Dallas, Texas, United States
Alamo Medical Research, San Antonio, Texas, United States
Advanced Healthcare, S.C., Milwaukee, Wisconsin, United States
Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, United States
Russian Center of Functional Surgical Gastroenterology, Krasnodar, , Russian Federation
Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital", Moscow, , Russian Federation
Out-patient clinic No. 2 of the Administration for the President of Russian Federation, Moscow, , Russian Federation
State Medical Stomatological University, Moscow, , Russian Federation
Out-patient clinic No. 3 of the Administration for the President of Russian Federation, Moscow, , Russian Federation
Rostov State Medical University, Rostov-on-Don, , Russian Federation
Dept of Gastroenterology and Nutrition, Saint Petersburg, , Russian Federation
Leningrad Regional Clinical Hospital, Saint-Petersburg, , Russian Federation
Saint-Petersburg State City Hospital No 26, Saint-Petersburg, , Russian Federation
Smolensk City Clinical Hospital No 1, Smolensk, , Russian Federation
2nd Terapy Department Military Medical Academy, St. Petersburg, , Russian Federation
All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia, St. Petersburg, , Russian Federation
St. Petersburg Central Medical Sanitary Department of Federal Biological Agency, St. Petersburg, , Russian Federation
Stavropol State Medical Academy, Stavropol, , Russian Federation
Yaroslav City Clinical Hospital No 2, Yaroslavl, , Russian Federation
Contact Details
Name: Hans Raskov, M.D.
Affiliation: Colotech A/S
Role: STUDY_DIRECTOR
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