Aspirin/Folate Prevention of Large Bowel Polyps
1 other identifier
interventional
1,121
2 countries
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Feb 1992
Longer than P75 for phase_2 colorectal-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1992
CompletedFirst Submitted
Initial submission to the registry
January 3, 2006
CompletedFirst Posted
Study publicly available on registry
January 5, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedMarch 13, 2020
March 1, 2020
January 3, 2006
March 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1 or more adenomas
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
Secondary Outcomes (2)
number of adenomas
For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
1 or more advanced lesions
For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
USC/Kaiser
Los Angeles, California, United States
University of Colorado
Denver, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
Henry Ford Health Sciences Center
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Toronto
Toronto, Ontario, Canada
Related Publications (9)
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.
PMID: 12621133RESULTFigueiredo 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.
PMID: 34762658DERIVEDPassarelli 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.
PMID: 34289971DERIVEDPassarelli 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.
PMID: 31401653DERIVEDPassarelli 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.
PMID: 31263057DERIVEDFedirko 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.
PMID: 28218420DERIVEDYip 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.
PMID: 27094489DERIVEDHazra 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.
PMID: 19923375DERIVEDCole 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.
PMID: 17551129DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John A Baron, MD, MSc
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 3, 2006
First Posted
January 5, 2006
Study Start
February 1, 1992
Study Completion
January 1, 2007
Last Updated
March 13, 2020
Record last verified: 2020-03