Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Crohn Disease (CD). Basic parameters: 16 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy, Netherlands, Poland, Portugal, Spain +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Development of Crohn's disease during the study period [Time frame: From enrolment until end of study follow-up (up to 3 years)]
Secondary outcome measures (4)
- Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From enrolment until end of study follow-up (up to 3 years)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Portugal · 4 centers
- Hospital Beatriz Ângelo — Lisbon
- Hospital da Luz Lisboa — Lisbon
- Hospital dos Capuchos — Lisbon
- Hospital Santa Maria — Lisbon
Netherlands · 2 centers
- AUMC — Amsterdam
- UMCG — Groningen
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Poland · 1 center
- Państwowy Instytut Medyczny MSWiA w Warszawie — Warsaw
Spain · 1 center
- Hospital Galdakao-Usansolo — Galdakao
Sweden · 1 center
- Örebro University Hospital — Örebro
Identifiers
NCT: NCT07316621 · PREDICT-CD