Crohn Disease (CD)
Conditions
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.
Interventions
None listed
Sponsors
GLSMED Learning Health S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Crohn's disease during the study period | From enrolment until end of study follow-up (up to 3 years) | Diagnosis confirmed according to established diagnostic criteria, specifically endoscopy and histopathology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
Countries
Italy, Netherlands, Poland, Portugal, Spain, Sweden
Contacts
CONTACTAna F Raimundo, PhD
Outcome results
None listed