Development and Validation of a Comorbidity Index in Crohn's Disease

NCT ID: NCT05253378

Last Updated: 2025-05-06

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

COMPLETED

Total Enrollment

458 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-04

Study Completion Date

2025-03-31

Brief Summary

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Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

Detailed Description

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Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients between 18 and 59 years old
2. Established diagnosis of CD with a minimum disease duration of 3 months
3. Disease considered by the treating gastroenterologist to have been stable for at least 3 months

Exclusion Criteria

1. Subject unable to comply with study procedures
2. Surgery for CD 3 months prior to inclusion visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Dr Laurent PEYRIN-BIROULET

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laurent PEYRIN-BIROULET

Vandœuvre-lès-Nancy, , France

Site Status

San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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France Italy

Other Identifiers

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2021PI158

Identifier Type: -

Identifier Source: org_study_id

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