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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03096717
Enrollment
300
Registered
2017-03-30
Start date
2017-01-01
Completion date
2021-01-21
Last updated
2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia in IBD

Brief 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.

Interventions

DIAGNOSTIC_TESTcolonoscopy and histology

colonic biopsies for detection of dysplasia

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of dysplasia in relation to therapy performed24 monthscolonic biopsies are performed in long standing inflammatory bowel disease in relation to dysplasia detection in patients on different drugs therapy

Countries

Italy

Contacts

Primary Contactalba panarese, medical doctor
albapanarese@libero.it3471401487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026