NCT06250361

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

February 9, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 15, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

IBDCROHNCD

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (1)

  • Number of predictive factors associated with a delayed diagnosis

    Day 1

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Written consent
  • Age ≥ 18 years

You may not qualify if:

  • Patient protected by the law
  • Patient without health cover

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Stéphane Nahon, PhD

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Mailhat, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2024

First Posted

February 9, 2024

Study Start

February 15, 2024

Primary Completion

February 15, 2025

Study Completion

June 15, 2025

Last Updated

February 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share