Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 7:11 AM
Study NCT ID:
NCT06250361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease
Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Organization:
Study Overview
Official Title:
Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease: the FAST Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST
Brief 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.
A questionnaire will be completed by the patients, each questionnaire has a patient section and a physician section.
Detailed 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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: