Effects of 5-ASA therapy on colonic polyps

• Research type

  Research Study

• Full title

  Effect of 5-Aminosalicylic Acid Therapy on The Biological Profile of Colonic Polyps

• IRAS ID

  26574

• Sponsor organisation

  Portsmouth Hospitals NHS Trust

• Eudract number

  2009-014674-18

• ISRCTN Number

  n/a

• Research summary

  Colonic polyps are a common finding at colonoscopy. They are important because they can turn into cancer. Aspirin and non steroidal anti-inflammatory drugs (NAIDS) have a protective effect on the development of polyps and colorectal cancer. However, these preparations carry side effects, including a risk of upper gastrointestinal bleeding, which limits their use as preventative agents. Aminosalycylates (5-ASAs) are similar and there is evidence from studies that their use reduces cancer risk in patients with ulcerative colitis. There has been limited research on their effects in patients without inflammatory bowel disease. We aim to assess whether 5-ASAs, either alone or in combination with aspirin, can reduce the rate at which polyps grow. As a secondary objective we aim to study the effects of 5-ASAs and aspirin on aspects of tumour survival. Our hypothesis is that 5-aminosaiycylates will flunce these markers and stop polyp tissue growing. We would measure factors known to be important in the survival of polyps and cancers, in particular products involved in establishing blood supply and signalling abnormal cells to die. Patients will be recruited from out patient rectal bleeding clinics where flexible sigmoidoscopies are performed. At time of diagnosis with a polyp a biopsy will be taken to look for markers of growth and survival. The patient will then receive 4 weeks of treatment with 5ASA, 5ASA aspirin, aspirin or placebo. The polyp will then be removed at routine follow up colonoscopy and the markers measured again to establish whether treatment has had any effect on them.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/111

• Date of REC Opinion

  19 Oct 2009

• REC opinion

  Further Information Favourable Opinion