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

January 31, 2024 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: 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.
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.
Time Frame: 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.
Day 1 from appearence of first symptoms and the diagnosis of the disease.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of predictive factors associated with a delayed diagnosis
Time Frame: Day 1
Number of predictive factors associated with a delayed diagnosis
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Stéphane Nahon, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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