Crohn's Disease Clinical Trials

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

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Netherlands
AUMC
RECRUITING
Amsterdam
UMCG
RECRUITING
Groningen
Poland
Państwowy Instytut Medyczny MSWiA w Warszawie
RECRUITING
Warsaw
Portugal
Hospital Beatriz Ângelo
RECRUITING
Lisbon
Hospital da Luz Lisboa
RECRUITING
Lisbon
Hospital dos Capuchos
RECRUITING
Lisbon
Hospital Santa Maria
RECRUITING
Lisbon
Spain
Hospital Galdakao-Usansolo
RECRUITING
Galdakao
Sweden
Örebro University Hospital
RECRUITING
Örebro
Contact Information
Primary
Ana F Raimundo, PhD
intercept@hospitaldaluz.pt
+351 926139262
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 10000
Treatments
First-degree relatives
Related Therapeutic Areas
Sponsors
Leads: GLSMED Learning Health S.A.

This content was sourced from clinicaltrials.gov