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Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps Clinical research trials and Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps. Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps clinical trial. Subjects frequently obtain the most expert healthcare possible for their Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps  Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
For Condition: Colon Cancer,prevention of colorectal cancer,Rectal Cancer
Status: No longer recruiting
Sponsor(s): Queen's Medical Centre ,
Synopsis: 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.
Details: OBJECTIVES: I. Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed. PROTOCOL 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. PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: /75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- 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) --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: - 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) --Patient Characteristics-- Age: 75 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: No active bleeding disorders Hepatic: Not specified Renal: Not specified Cardiovascular: No unstable heart conditions Pulmonary: No unstable asthma Other: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardLogan, Study Chair, Queen's Medical Centre
Whiston Hospital
Prescot Merseyside, England, L35 5DR
United Kingdom
University of Wales College of Medicine
Cardiff, Wales, CF14 4XN
United Kingdom
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, B9 5SS
United Kingdom
Royal Gwent Hospital
Newport Gwent, , NP9 2UB
United Kingdom
City Hospital - Birmingham
Birmingham, England, B18 7QH
United Kingdom
Southport and Formby District General Hospital
Merseyside, England, PR8 6NJ
United Kingdom
Derby City General Hospital
Derby, England, DE22 3NE
United Kingdom
Salford Royal Hospitals NHS Trust
Salford, England, M6 8HD
United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Southmead Hospital
Bristol, England, BS10 5NB
United Kingdom
Rotherham District General Hospital-NHS Trust
Rotherham, , S60 2UD
United Kingdom
Frenchay Hospital
Bristol, England, BS16 1LE
United Kingdom
King's Mills Hospital
Nottinghamshire, , NG17 4JL
United Kingdom
Merthyr Tydfil Hospital
Merthyr, England,
United Kingdom
Whiteabbey Hospital
Newtownabbey, Northern Ireland,
United Kingdom
Sheffield Teaching Hospitals
Sheffield, England, S1O 2JF
United Kingdom
Queen's Medical Centre
Nottingham, England, NG7 2UH
United Kingdom
Trafford General Hospital
Manchester, England, M31 3SL
United Kingdom
East Glamorgan Hospital
Lhantrisant, , CF72 8XR
United Kingdom
Princess of Wales Hospital
Bridgend, Wales, CF31 1JP
United Kingdom
Northern General Hospital
Sheffield, England, S5 7AU
United Kingdom
North Manchester Healthcare NHS Trust
Manchester, , M8 6RB
United Kingdom
Wythenshawe Hospital
Manchester, England, M23 9LJ
United Kingdom
Wordsley Hospital
Dudley, England, DY8 5QX
United Kingdom
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA
United Kingdom
Manchester Royal Infirmary
Manchester, England, M13 9WL
United Kingdom
Glenfield Hospital
Leicester, England, LE3 9QP
United Kingdom
Solihull Hospital
Solihull, England, B91 3AH
United Kingdom
Antrim Hospital
Antrim, England, BR41 2RL
United Kingdom
Royal Liverpool and Broadgreen Hospitals
Liverpool, England, L7 8XP
United Kingdom
Selly Oak Hospital
Birmingham, , B29 6JD
United Kingdom
Bristol Royal Infirmary
Bristol, England, BS2 8HW
United Kingdom
Additional Information:
Study ID Numbers: CDR0000069273; EU-20045,QMC-UKCAP
Study Start Date: May 1997
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033319
Other Colon Cancer Studies:
1. Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
2. High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed
3. Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
4. Sulindac and Plant Compounds in Preventing Colon Cancer
Related Studies:
Other Colon Cancer Clinical Trials
Other Northern Ireland Clinical Trials
Other Belfast Clinical Trials
Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps
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