Prospective Risk Evaluation and Detection of Crohn's Disease in First-degree Relatives

Обзор

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.

Первичные конечные точки

• Development of Crohn's disease during the study period [Срок оценки: From enrolment until end of study follow-up (up to 3 years)]

Вторичные конечные точки (4)

• Proportion of first-degree relatives classified as high risk according to the PREDICT-CD risk prediction algorithm [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrolment until end of study follow-up (up to 3 years)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Португалия · 4 центра

• Hospital Beatriz Ângelo — Lisbon
• Hospital da Luz Lisboa — Lisbon
• Hospital dos Capuchos — Lisbon
• Hospital Santa Maria — Lisbon

Нидерланды · 2 центра

• AUMC — Amsterdam
• UMCG — Groningen

Италия · 1 центр

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

Польша · 1 центр

• Państwowy Instytut Medyczny MSWiA w Warszawie — Warsaw

Испания · 1 центр

• Hospital Galdakao-Usansolo — Galdakao

Швеция · 1 центр

• Örebro University Hospital — Örebro

Идентификаторы

NCT: NCT07316621 · PREDICT-CD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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