Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease

NCT ID: NCT06250361

Last Updated: 2024-02-09

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

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-06-15

Brief Summary

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The goal of this observational study is to determine the factors associated with a delayed diagnosis and/or an immediately complicated disease for CD patients.

A questionnaire will be completed by the patients, each questionnaire has a patient section and a physician section.

Detailed Description

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Number of patients expected : at least 600, coming from all types of practices (ANGH (expert hospitals), GETAID (expert university hospitals) and CREGG (expert private practice)).

Recruitment period : 1 year

Primary endpoint : The primary endpoint is the description of the factors linked to:

* The IBD
* The patient (see patient questionnaire in annex 1)
* The health care system
* The patient's self-care

Secondary endpoint :

* Validation of the "red flags" in a prospective cohort.
* Comparison with the EPIMAD population, especially the location and severity.

Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire completion

A questionnaire will be completed by the participant and their gastroenterologist. Estimated completion time is 30 minutes for the patient, 10 minutes for the gastroenterologist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Crohn's disease diagnosed less than a year prior to inclusion
* Written consent
* Age ≥ 18 years

Exclusion Criteria

* Diagnosis of Crohn's disease more than one year before inclusion
* Patient protected by the law
* Patient without health cover
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Nahon, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Central Contacts

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Charlotte Mailhat, PhD

Role: CONTACT

+ 33 9 72 57 61 60

Other Identifiers

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GETAID-2023-01

Identifier Type: -

Identifier Source: org_study_id

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