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Trial record 6 of 6 for:    "Colorectal Adenoma" | "Fibrinolytic Agents"

Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

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. Identifier: NCT00033319
Recruitment Status : Unknown
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : July 1, 2003
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin and/or folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously.

PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic acid in preventing the recurrence of colorectal polyps.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: folic acid Drug: acetylsalicylic acid Not Applicable

Detailed Description:


  • Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive oral aspirin and oral folic acid daily.
  • Arm II: Patients receive oral aspirin and oral placebo daily.
  • Arm III: Patients receive oral placebo and oral folic acid daily.
  • Arm IV: Patients receive 2 oral placebos daily. In all arms, treatment continues for 3 years in the absence of unacceptable toxicity.

After completion of the 3-year intervention, all patients undergo a surveillance colonoscopy.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
Study Start Date : May 1997

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal adenoma removed within the past 6 months

    • Greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal

      • OR
    • Any size with a history of prior colorectal adenoma removal(s)
  • Removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery
  • Removal must be considered complete with follow-up to be done within 6 months
  • No prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy)



  • 75 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • No active bleeding disorders


  • Not specified


  • Not specified


  • No unstable heart conditions


  • No unstable asthma


  • Not pregnant and no potential to become pregnant within the next 3 years
  • No unstable diabetes
  • No active upper gastrointestinal ulceration
  • No known aspirin intolerance or sensitivity
  • No other serious medical conditions that would preclude study participation


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics


  • No other concurrent folic acid
  • No concurrent anticoagulants
  • No other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00033319

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United Kingdom
Antrim Hospital
Antrim, England, United Kingdom, BR41 2RL
City Hospital - Birmingham
Birmingham, England, United Kingdom, B18 7QH
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, United Kingdom, B9 5SS
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
Frenchay Hospital
Bristol, England, United Kingdom, BS16 1LE
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Derby City General Hospital
Derby, England, United Kingdom, DE22 3NE
Wordsley Hospital
Dudley, England, United Kingdom, DY8 5QX
Glenfield Hospital
Leicester, England, United Kingdom, LE3 9QP
Royal Liverpool and Broadgreen Hospitals
Liverpool, England, United Kingdom, L7 8XP
Manchester Royal Infirmary
Manchester, England, United Kingdom, M13 9WL
Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LJ
Trafford General Hospital
Manchester, England, United Kingdom, M31 3SL
Southport and Formby District General Hospital
Merseyside, England, United Kingdom, PR8 6NJ
Merthyr Tydfil Hospital
Merthyr, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Whiston Hospital
Prescot Merseyside, England, United Kingdom, L35 5DR
Salford Royal Hospitals NHS Trust
Salford, England, United Kingdom, M6 8HD
Sheffield Teaching Hospitals
Sheffield, England, United Kingdom, S1O 2JF
Northern General Hospital
Sheffield, England, United Kingdom, S5 7AU
Solihull Hospital
Solihull, England, United Kingdom, B91 3AH
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Whiteabbey Hospital
Newtownabbey, Northern Ireland, United Kingdom
Princess of Wales Hospital
Bridgend, Wales, United Kingdom, CF31 1JP
University of Wales College of Medicine
Cardiff, Wales, United Kingdom, CF14 4XN
Selly Oak Hospital
Birmingham, United Kingdom, B29 6JD
East Glamorgan Hospital
Lhantrisant, United Kingdom, CF72 8XR
North Manchester Healthcare NHS Trust
Manchester, United Kingdom, M8 6RB
Royal Gwent Hospital
Newport Gwent, United Kingdom, NP9 2UB
King's Mills Hospital
Nottinghamshire, United Kingdom, NG17 4JL
Rotherham District General Hospital-NHS Trust
Rotherham, United Kingdom, S60 2UD
Sponsors and Collaborators
Queen's Medical Centre
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Study Chair: Richard Logan, MD Queen's Medical Centre

Layout table for additonal information Identifier: NCT00033319     History of Changes
Other Study ID Numbers: CDR0000069273
First Posted: July 1, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: December 2002
Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer
Additional relevant MeSH terms:
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Fibrinolytic Agents
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Folic Acid
Vitamin B Complex
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors