Dysplasia in Inflammatory Chronic Idiopathic Colitis Long-standing

NCT ID: NCT03096717

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-01-21

Brief Summary

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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

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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

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Dysplasia in IBD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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colonoscopy and histology

colonic biopsies for detection of dysplasia

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role lead

Responsible Party

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alba panarese

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alba Panarese

Castellana Grotte, Apulia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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alba panarese, medical doctor

Role: CONTACT

3471401487

Facility Contacts

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alba panarese

Role: primary

3471401487

Other Identifiers

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7

Identifier Type: -

Identifier Source: org_study_id

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