Dysplasia in Inflammatory Chronic Idiopathic Colitis Long-standing

Dysplasia in IBD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096717
• Other study ID #: 7
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: January 21, 2021

Study information

• Verified date: March 2020
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: alba panarese, medical doctor
• Phone: 3471401487
• Email: albapanarese[@]libero.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 21, 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• long standing colonic inflammatory bowel disease

• clinical, endoscopic and histological remission

• completeness of data

Exclusion Criteria:

• important comorbidities

• family history of colorectal cancer

• insufficient data

Related Conditions & MeSH terms

• Colitis
• Dysplasia in IBD

Intervention

Diagnostic Test:
• colonoscopy and histology
colonic biopsies for detection of dysplasia

Locations

Country	Name	City	State
Italy	Alba Panarese	Castellana Grotte	Puglia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of dysplasia in relation to therapy performed	colonic biopsies are performed in long standing inflammatory bowel disease in relation to dysplasia detection in patients on different drugs therapy	24 months