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Not yet recruitingNCT06250361FASTUpdated Feb 9, 2024

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

An observational study in Crohn Disease, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Crohn Disease

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Keywords

  • IBD
  • CROHN
  • CD
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 600 is above the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives is the lead sponsor of 35 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Crohn's disease, going to ANGH (expert hospitals), GETAID (expert university hospitals) and CREGG (expert private practice) centres, who have been diagnosed within the year before the inclusion visit.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of Crohn's disease more than one year before inclusion
  • Patient protected by the law
  • Patient without health cover
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Interventions

  • OtherQuestionnaire 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 from appearence of first symptoms and the diagnosis of the disease.

  2. 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.

    Time frame: Day 1 from appearence of first symptoms and the diagnosis of the disease.

  3. 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.

    Time frame: Day 1 from appearence of first symptoms and the diagnosis of the disease.

Secondary outcomes

  1. Number of predictive factors associated with a delayed diagnosis

    Number of predictive factors associated with a delayed diagnosis

    Time frame: Day 1

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06250361
Lead sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Responsible party
Sponsor
First posted
Feb 9, 2024
Start date
Feb 15, 2024 (estimated)
Primary completion
Feb 15, 2025 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
Feb 9, 2024

Study contacts

Charlotte Mailhat, PhD
Contact
cmailhat@getaid.org
+ 33 9 72 57 61 60
Stéphane Nahon, PhD
principal investigator · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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