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Chemoprevention of Colorectal Adenomas
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Prevention
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Active
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40 to 75
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Pharmaceutical / Industry
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COLO CP-01-US
NCT00486512
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Trial Description
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. Further Study Information 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. Eligibility Criteria Inclusion Criteria: - Patients 40-75 years of age, both sexes.
- Colonoscopy including the cecum at trial entry
- The removed adenoma(s) have be to tubular, tubulovillous or villous, and fulfill one of the three following criteria:
1. one adenoma with diameter ≥ 1 cm 2. ≥ 2 adenomas of any size 3. an adenoma of any size and familial disposition for colorectal cancer, as long as the person is a first degree relative with a colorectal cancer patient Exclusion Criteria: - Familial Adenomatous Polyposis Syndrome
- Member of a family with hereditary non-polyposis colorectal cancer (HNPCC)
- Proctocolectomy (colonic and/or rectum resection permitted).
- Inflammatory bowel disease (Crohn´s disease, Ulcerative Colitis).
- Ischemic cardiovascular disease.
- Patients with known gastro-duodenal ulcer at time of inclusion.
- Cancer within the past 5 years
Trial Contact Information
Trial Lead Organizations/Sponsors Colotech A/S | Hans Raskov, M.D. | | Study Director |
Trial Sites
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| U.S.A. |
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| Florida |
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Clearwater |
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| | | | | | | | Advance Digestive Care |
| | | Umesh Choudry, M.D. | Principal Investigator |
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Orlando |
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| | | Internal Medicine Specialists |
| | | Avanish M Aggarwal, M.D. | Principal Investigator |
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| Indiana |
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Anderson |
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| | | | Central Indiana Gastroenterology Group |
| | | Thomas V Nowak, M.D. | Principal Investigator |
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| Iowa |
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Davenport |
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| | | | Gastrointestinal Clinic Of Quad Cities |
| | | Bavikatte N Shivakumar, M.D. | Principal Investigator |
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| Kentucky |
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Lexington |
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| | | | Lucille P. Markey Cancer Center at University of Kentucky |
| | | Houssam E Mardini, M.D. | Principal Investigator |
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| Mississippi |
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Tupelo |
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| | | | Digestive Health Specialists, PA - Tupelo |
| | | Stephen T Amann, M.D. | Principal Investigator |
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| New York |
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Seaford |
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| | | | Massapequa Gastroenterology Associates |
| | | Corina Serer, M.D. | Principal Investigator |
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Stony Brook |
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| | | Stony Brook University Cancer Center |
| | | Robert J Richards, M.D. | Principal Investigator |
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| North Carolina |
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Winston-Salem |
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| | | | Digestive Health Specialists, PA - Winston-Salem |
| | | William C Bray, M.D. | Principal Investigator |
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| Oregon |
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Portland |
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| | | | Northwest Gastroenterology Clinic |
| | | Roland W Bennetts Jr, M.D. | Principal Investigator |
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| Pennsylvania |
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Lancaster |
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| | | | Regional Gastroenterology Associates of Lancaster, Limited at Lancaster General Health Campus |
| | | T. Raymond Foley, M.D. | Principal Investigator |
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| Virginia |
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Christianburg |
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| | | | Carilion New River Valley Medical Center |
| | | Mark A Ringold, M.D. | Principal Investigator |
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| Wisconsin |
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Milwaukee |
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| | | | Good Hope Road Clinic |
| | | Vasanth K Siddalingaiah, M.D. | Principal Investigator |
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| Russia |
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Krasnodar |
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| | | | Russian Center of Functional Surgical Gastroenterology |
| | | Vladimir V Onopriev, M.D. | Principal Investigator |
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Moscow |
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| | | Central Clinical and Diagnostic Complex of the FSD "National Medical and Surgeon Centre named after N.I. Pirogov of the Federal Health and Social Development Agency |
| | | Emiliya Yakovenko, M.D. | Principal Investigator |
| | | Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital" |
| | | Alexey Loginov, M.D., Ph.D. | Principal Investigator |
| | | Mikhail Mantcerov, M.D. | Principal Investigator |
| | | Out-patient clinic No. 2 of the Administration for the President of Russian Federation |
| | | Elena Burdina, M.D. | Principal Investigator |
| | | Out-patient clinic No. 3 of the Administration for the President of Russian Federation |
| | | Sergei Burkov, M.D. | Principal Investigator |
| | | State Medical Stomatological University |
| | | Igor Maev, M.D., Ph.D. | Principal Investigator |
| | | State Scientific Center for Coloproctology |
| | | Victor Veselov, M.D., Ph.D. | Principal Investigator |
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Rostov-on-Don |
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| | | City Hospital No. 20 |
| | | Alexander Tkachev, M.D. | Principal Investigator |
| | | Rostov State Medical University |
| | | Alexei Iakovlev, M.D. | Principal Investigator |
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Saint Petersburg |
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| | | Dept of Gastroenterology and Nutrition |
| | | Andrey Baranovsky, M.D. | Principal Investigator |
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Saint-Petersburg |
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| | | Leningrad Regional Clinical Hospital |
| | | Andrew Philin, M.D. | Principal Investigator |
| | | Saint-Petersburg State City Hospital No 26 |
| | | Vladimir Simanenkov, M.D. | Principal Investigator |
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Smolensk |
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| | | Smolensk City Clinical Hospital No 1 |
| | | Aleksey Borsukov, M.D. | Principal Investigator |
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St. Petersburg |
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| | | 2nd Terapy Department Military Medical Academy |
| | | Vladimir Grinevich, M.D., Ph.D. | Principal Investigator |
| | | All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia |
| | | Oleg Sablin, M.D., Ph.D. | Principal Investigator |
| | | St. Petersburg Central Medical Sanitary Department of Federal Biological Agency |
| | | Elena Sishkova, M.D. | Principal Investigator |
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Stavropol |
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| | | Stavropol State Medical Academy |
| | | Victor Pasechnikov, M.D. | Principal Investigator |
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Yaroslav |
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| | | Yaroslav City Clinical Hospital No 2 |
| | | Alevander Khokhlov, M.D. | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00486512
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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