Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-35
SponsorGLSMED Learning Health S.A.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The first-degree relative without a previous diagnosis of Inflammatory Bowel Disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: First-degree relatives
Trial outcomes
Primary outcomes
1
Development of Crohn's disease during the study period
Diagnosis confirmed according to established diagnostic criteria, specifically endoscopy and histopathology
Time frame
From enrolment until end of study follow-up (up to 3 years)Secondary outcomes
1
Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm
Proportion of enrolled first-degree relatives whose calculated risk score exceeds the predefined threshold for high-risk classification, based on the PREDICT-CD risk prediction algorithm incorporating serological biomarkers and lifestyle/environmental risk factors.
Time frame
From enrolment until end of study follow-up (up to 3 years)2
Clinical and lifestyle characteristics of high-risk individuals who develop inflammatory bowel disease
Characterization of high-risk participants who develop incident inflammatory bowel disease during follow-up, including: time from study enrolment to diagnosis; disease phenotype and disease behaviour at diagnosis; disease severity at diagnosis; early-life risk factors; dietary, nutritional and lifestyle factors; smoking exposure; medical and surgical history.
Time frame
From enrolment until end of study follow-up (up to 3 years)3
Incidence of newly diagnosed immune-mediated inflammatory diseases other than Crohn's disease
Number and proportion of participants diagnosed with a new immune-mediated inflammatory disease other than Crohn's disease during study follow-up, based on investigator-confirmed clinical diagnoses.
Time frame
From enrolment until end of study follow-up (up to 3 years)4
Participant-reported willingness to receive predictive risk information and participate in preventive interventions
Acceptability will be assessed using a study-specific participant questionnaire. The questionnaire will evaluate willingness to receive information regarding Crohn's disease risk, willingness to undergo additional monitoring, willingness to participate in disease-interception or prevention studies, and concerns and preferences related to predictive testing. Responses will be recorded as categorical and Likert-scale measures and summarized descriptively.
Time frame
From enrolment until end of study follow-up (up to 3 years)Sponsors and contacts
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Source ClinicalTrials.gov