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Halfvarsson",{"type":174,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100617284","prospective-risk-evaluation-and-detection-of-crohns-disease-in-first-degree-relatives-100617284",false,"NCT07316621","Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives","PREDICT-CD","Inclusion Criteria:\n\n* Male or female participants, between 16 and 35 years old\n* FDR (parent, full-siblings or offspring) from a patient with an established diagnosis of CD\n* Participants able to understand the information provided to them and to give written informed assent or consent for the study.\n\nExclusion Criteria:\n\n* Prior diagnosis of IBD\n* Any legal or medical condition that limits the information and participation in the study\n* Inability to verify CD diagnosis in the proband\n* Participants unwilling or unable to provide informed written consent\n* Participants unwilling or unable to donate blood for serum",true,"ALL","16 Years","35 Years",{"count":187,"type":188},10000,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nTo 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.\n\nAt 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.",[192],"Crohn Disease (CD)","2026-07-27",{"date":195,"type":196},"2026-07-29","ACTUAL",{"date":198,"type":196},"2026-04-01",{"date":200,"type":188},"2029-12-31",{"name":5,"class":6},10]