NCT03096717

Dysplasia in Inflammatory Chronic Idiopathic Colitis Long-standing

Incidence of Dysplasia and Colorectal Cancer in Patients With Chronic Idiopathic Inflammatory Colitis Treated With Biologics, Mesalamine, and Immunosuppressive Drug Combinations

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chronic intestinal inflammation produce dysplasia more frequently than the normal population. The therapies protect against these changes, but do not rule out dysplasia. It is not known the effect of different therapies protection.

Detailed description

The literature data show that the inflammatory bowel diseases (rectal ulcerative colitis and Crohn's disease) determine an increased risk of developing dysplasia and cancer of the colon and rectum, for the chronic inflammation that they fee, with the differences that the two diseases arise. The progression from normal mucosa to dysplasia and then to cancer is more rapid than in the adenoma-carcinoma sequence. In patients with idiopathic chronic inflammatory colitis drug therapies in use reduce the incidence of dysplasia. A systematic review concluded in favor of a chemo preventive effect of mesalazine. In any case, it has been reported protective association between use of mesalazine and cancer associated with colitis (colitis Associated carcinoma CAC) with an odds ratio of 0.51 per CAC / dysplasia. This data, in subsequent studies, including recent ones, have remained controversial. The introduction of biological drugs in the treatment of patients with inflammatory bowel disease (IBD) has changed the quality of life and also the natural history of the disease. It is not known what biological drugs have improved the clinical history of these diseases by changing the incidence of dysplasia and colorectal cancer. The treatment of idiopathic inflammatory bowel diseases (IBD), the last decade has seen profound changes and, now, the use of biological drugs is frequent in the moderate-severe forms, especially if extended. Mesalazine has in the indication of mild to moderate forms of therapy.

Conditions

• Dysplasia in IBD

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	colonoscopy and histology	colonic biopsies for detection of dysplasia

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-05-30
• Completion: 2021-01-21
• First posted: 2017-03-30
• Last updated: 2020-03-19

Locations

1 site across 1 country: Italy