Aspirin/Folate Prevention of Large Bowel Polyps
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00272324 |
Recruitment Status :
Completed
First Posted : January 5, 2006
Last Update Posted : March 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer Polyps Adenomas | Drug: Aspirin Drug: Folate | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 1121 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Aspirin/Folate Prevention of Large Bowel Polyps |
Study Start Date : | February 1992 |
Study Completion Date : | January 2007 |

- 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
- 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
- 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

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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Contraindication to aspirin use, including:
- documented peptic ulcer disease in the past 20 years
- aspirin sensitivity
- bleeding diathesis, including hemorrhagic stroke
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272324
United States, California | |
USC/Kaiser | |
Los Angeles, California, United States | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States | |
United States, Michigan | |
Henry Ford Health Sciences Center | |
Detroit, Michigan, United States | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States | |
United States, New Hampshire | |
Dartmouth Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03766 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States | |
Canada, Ontario | |
University of Toronto | |
Toronto, Ontario, Canada |
Principal Investigator: | John A Baron, MD, MSc | Dartmouth-Hitchcock Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00272324 |
Other Study ID Numbers: |
5R01CA059005-12 ( U.S. NIH Grant/Contract ) |
First Posted: | January 5, 2006 Key Record Dates |
Last Update Posted: | March 13, 2020 |
Last Verified: | March 2020 |
Colorectal neoplasms Adenomatous polyps |
Adenoma Polyps Neoplasms Pathological Conditions, Anatomical Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |