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

Crohn Disease Clinical Trial

— FAST  

Official title:

Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease: the FAST Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250361
• Other study ID #: GETAID-2023-01
• Status: Not yet recruiting
• Start date: February 15, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: January 2024
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: Charlotte Mailhat, PhD
• Phone: + 33 9 72 57 61 60
• Email: cmailhat[@]getaid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: June 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient's visits to doctors between the appearance of the first symptoms and the diagnosis of the disease.	Number of patient's visits to doctors between the appearance of the first symptoms and the diagnosis of the disease.	Day 1 from appearence of first symptoms and the diagnosis of the disease.
Primary	Number of exams performed between the appearance of the first symptoms and the diagnosis of the disease.	Number of exams performed between the appearance of the first symptoms and the diagnosis of the disease.	Day 1 from appearence of first symptoms and the diagnosis of the disease.
Primary	Number of medical specialties consulted between the appearance of the first symptoms and the diagnosis of the disease.	Number of medical specialties consulted between the appearance of the first symptoms and the diagnosis of the disease.	Day 1 from appearence of first symptoms and the diagnosis of the disease.
Secondary	Number of predictive factors associated with a delayed diagnosis	Number of predictive factors associated with a delayed diagnosis	Day 1