- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00272324
Aspirin/Folate Prevention of Large Bowel Polyps
March 11, 2020 updated by: Dartmouth-Hitchcock Medical Center
This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel among subjects with a recent history of these tumors.
The study is a randomized, double-blind, placebo-controlled trial with a 2 x 3 factorial design.
Study Type
Interventional
Enrollment
1121
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada
- University of Toronto
-
-
-
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California
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Los Angeles, California, United States
- USC/Kaiser
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Colorado
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Denver, Colorado, United States
- University of Colorado
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Iowa
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Iowa City, Iowa, United States
- University of Iowa
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Michigan
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Detroit, Michigan, United States
- Henry Ford Health Sciences Center
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Minnesota
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Minneapolis, Minnesota, United States
- University of Minnesota
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth Hitchcock Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States
- University of North Carolina
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Ohio
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Cleveland, Ohio, United States
- Cleveland Clinic Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- One neoplastic polyp removed within three months of study entry or within 16 months of study entry if over 1 cm in size or if subject has had a lifetime history of at least two polyps, with the entire large bowel seen by colonoscopy to be free of further polyps within 3 months of entry.
- An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
- Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
- Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
- Age between 21 and 80 years at the time of the intake colonoscopy.
- For women of childbearing potential, agreement to use effective birth control for the duration of the study.
- Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
- Not randomized previously or currently in a chemoprevention trial, except for the: "Nutritional Prevention of Large Bowel Polyps" Study (Polyps Prevention Study I); and brief participation in the "VA Cooperative Study" with no continuing involvement.
Exclusion Criteria:
- Invasive carcinoma in any colonic polyp removed.
- Familial colonic polyposis syndromes.
- Ulcerative colitis or Crohn's disease.
- Malabsorption syndrome (e.g. pancreatic insufficiency).
- Large bowel resection for any reason.
- Diagnosed narcotic or alcohol dependence
Contraindication to aspirin use, including:
- documented peptic ulcer disease in the past 20 years
- aspirin sensitivity
- bleeding diathesis, including hemorrhagic stroke
Likelihood of NSAID use
- recurring arthritis or other musculo-skeletal problems
- frequent NSAID use in 5 years preceding
- history of stroke or TIAs
- history of angina or myocardial infarction
- desire to take aspirin for the prevention of cardiovascular disease
- Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
- Pregnancy or lactation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1 or more adenomas
Time Frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
|
colorectal adenomas detected at follow-up colonoscopy
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For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of adenomas
Time Frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
|
colorectal adenomas detected at follow-up colonoscopy
|
For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
|
1 or more advanced lesions
Time Frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
|
adenomas measuring at least 1 cm in diameter or with tubulovillous or villous features, severe dysplasia, or invasive cancer
|
For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John A Baron, MD, MSc, Dartmouth-Hitchcock Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baron JA, Cole BF, Sandler RS, Haile RW, Ahnen D, Bresalier R, McKeown-Eyssen G, Summers RW, Rothstein R, Burke CA, Snover DC, Church TR, Allen JI, Beach M, Beck GJ, Bond JH, Byers T, Greenberg ER, Mandel JS, Marcon N, Mott LA, Pearson L, Saibil F, van Stolk RU. A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med. 2003 Mar 6;348(10):891-9. doi: 10.1056/NEJMoa021735.
- Figueiredo JC, Passarelli MN, Wei W, Ahnen DJ, Morris JS, Corley L, Mehta T, Bartley AN, McKeown-Eyssen G, Bresalier RS, Barry EL, Goel A, Hernandez Mesa G, Hamilton SR, Baron JA. Proliferation, apoptosis and their regulatory protein expression in colorectal adenomas and serrated lesions. PLoS One. 2021 Nov 11;16(11):e0258878. doi: 10.1371/journal.pone.0258878. eCollection 2021.
- Passarelli MN, Mott LA, Barry EL, Rees JR, Baron JA. Oral Antibiotics and Risk of New Colorectal Adenomas During Surveillance Follow-up. Cancer Epidemiol Biomarkers Prev. 2021 Oct;30(10):1974-1976. doi: 10.1158/1055-9965.EPI-21-0323. Epub 2021 Jul 21.
- Passarelli MN, Barry EL, Rees JR, Mott LA, Zhang D, Ahnen DJ, Bresalier RS, Haile RW, McKeown-Eyssen G, Snover DC, Cole BF, Baron JA. Folic acid supplementation and risk of colorectal neoplasia during long-term follow-up of a randomized clinical trial. Am J Clin Nutr. 2019 Oct 1;110(4):903-911. doi: 10.1093/ajcn/nqz160.
- Passarelli MN, Barry EL, Rees JR, Mott LA, Ahnen DJ, Baron JA. Body Composition and Aspirin Dose for Colorectal Adenoma Prevention in a Randomized Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2019 Jul;28(7):1262-1265. doi: 10.1158/1055-9965.EPI-19-0205.
- Fedirko V, McKeown-Eyssen G, Serhan CN, Barry EL, Sandler RS, Figueiredo JC, Ahnen DJ, Bresalier RS, Robertson DJ, Anderson CW, Baron JA. Plasma lipoxin A4 and resolvin D1 are not associated with reduced adenoma risk in a randomized trial of aspirin to prevent colon adenomas. Mol Carcinog. 2017 Aug;56(8):1977-1983. doi: 10.1002/mc.22629. Epub 2017 Mar 6.
- Yip WK, Bonetti M, Cole BF, Barcella W, Wang XV, Lazar A, Gelber RD. Subpopulation Treatment Effect Pattern Plot (STEPP) analysis for continuous, binary, and count outcomes. Clin Trials. 2016 Aug;13(4):382-90. doi: 10.1177/1740774516643297. Epub 2016 Apr 19.
- Hazra A, Selhub J, Chao WH, Ueland PM, Hunter DJ, Baron JA. Uracil misincorporation into DNA and folic acid supplementation. Am J Clin Nutr. 2010 Jan;91(1):160-5. doi: 10.3945/ajcn.2009.28527. Epub 2009 Nov 18.
- Cole BF, Baron JA, Sandler RS, Haile RW, Ahnen DJ, Bresalier RS, McKeown-Eyssen G, Summers RW, Rothstein RI, Burke CA, Snover DC, Church TR, Allen JI, Robertson DJ, Beck GJ, Bond JH, Byers T, Mandel JS, Mott LA, Pearson LH, Barry EL, Rees JR, Marcon N, Saibil F, Ueland PM, Greenberg ER; Polyp Prevention Study Group. Folic acid for the prevention of colorectal adenomas: a randomized clinical trial. JAMA. 2007 Jun 6;297(21):2351-9. doi: 10.1001/jama.297.21.2351.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1992
Study Completion
January 1, 2007
Study Registration Dates
First Submitted
January 3, 2006
First Submitted That Met QC Criteria
January 3, 2006
First Posted (Estimate)
January 5, 2006
Study Record Updates
Last Update Posted (Actual)
March 13, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Pathological Conditions, Anatomical
- Adenoma
- Polyps
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 5R01CA059005-12 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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