Crohn DiseaseFASTNCT06250361
Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease
An observational study of Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Questionnaire completion
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 15 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Crohn's disease diagnosed less than a year prior to inclusion
- Written consent
- Age ≥ 18 years
Who cannot join
- Diagnosis of Crohn's disease more than one year before inclusion
- Patient protected by the law
- Patient without health cover
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- Crohn Disease
- Being tested
- Questionnaire completion
- Keywords
- IBD, CROHN, CD
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire completionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Nahon, PhD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250361
- Sponsor's protocol ID
- GETAID-2023-01
- Acronym
- FAST
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease: the FAST Study
- ClinicalTrials.gov ID
- NCT06250361
- Acronym / sponsor ID
- FAST / GETAID-2023-01
- Conditions
- Crohn Disease
- Keywords
- IBD, CROHN, CD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Crohn's disease diagnosed less than a year prior to inclusion
- Written consent
- Age ≥ 18 years
Key exclusion criteria (3 listed)
- Diagnosis of Crohn's disease more than one year before inclusion
- Patient protected by the law
- Patient without health cover
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire completionA questionnaire will be completed by the participant and their gastroenterologist. Estimated completion time is 30 minutes for the patient, 10 minutes for the gastroenterologist. | Other | – |
Primary outcome
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.
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.
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.
1 secondary outcome
Number of predictive factors associated with a delayed diagnosis
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Nahon, PhD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Mailhat, PhD (+ 33 9 72 57 61 60, cmailhat@getaid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.