Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10,000
- Locations
- 10
- Primary Endpoint
- Development of Crohn's disease during the study period
Study Overview
Brief Summary
The PREDICT-CD study aims to validate a risk score for the development of Crohn's disease, based on serological biomarkers and lifestyle-related factors. Given that having a family member with the disease is the strongest known risk factor, the target population will consist of first-degree relatives (aged 16 to 35) of individuals diagnosed with Crohn's disease.
This study will be conducted within Work Package 3 (WP3) of the INTERCEPT project, a consortium funded by the Innovative Health Initiative (IHI). The research will take place across 28 centres in seven countries: Portugal, Spain, France, Italy, the Netherlands, Sweden, and Poland.
To achieve the study objectives, individuals with Crohn's disease (referred to as patients) will be invited to participate and to engage their eligible first-degree relatives. At the baseline visit, the patient's physician will complete a clinical questionnaire covering disease history, treatments, and previous interventions.
At the same time, first-degree relatives (parents, siblings, or children) will donate a blood sample for serum isolation and, optionally, a whole blood and stool sample. They will also complete a questionnaire regarding their health status, habits, and preferences. Follow-up questionnaires will be administered every six months to monitor the onset of symptoms or behavioural changes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female participants, between 16 and 35 years old
- •FDR (parent, full-siblings or offspring) from a patient with an established diagnosis of CD
- •Participants able to understand the information provided to them and to give written informed assent or consent for the study.
Exclusion Criteria
- •Prior diagnosis of IBD
- •Any legal or medical condition that limits the information and participation in the study
- •Inability to verify CD diagnosis in the proband
- •Participants unwilling or unable to provide informed written consent
- •Participants unwilling or unable to donate blood for serum
Arms & Interventions
First-degree relatives
Outcomes
Primary Outcomes
Development of Crohn's disease during the study period
Time Frame: From enrolment until end of study follow-up (up to 3 years)
Diagnosis confirmed according to established diagnostic criteria, specifically endoscopy and histopathology
Assess the performance of a risk model for at-risk population for CD
Time Frame: through study development, an average of 1-3 year
The model will integrate measures of predefined serum biomarkers of at-risk population (first degree relatives of CD patients) with clinical and lifestyle factors. The performance can than be assessed by the risk prediction of participants which are then diagnosed with CD.
Secondary Outcomes
- Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm(From enrolment until end of study follow-up (up to 3 years))
- Clinical and lifestyle characteristics of high-risk individuals who develop inflammatory bowel disease(From enrolment until end of study follow-up (up to 3 years))
- Incidence of newly diagnosed immune-mediated inflammatory diseases other than Crohn's disease(From enrolment until end of study follow-up (up to 3 years))
- Participant-reported willingness to receive predictive risk information and participate in preventive interventions(From enrolment until end of study follow-up (up to 3 years))
- Prevalence of risk factors in FDRs developing IBD(throughout the study, in average 1-3 years)