Evidence-based Screening Strategies for Celiac Disease

• Conditions: Celiac Disease
• Interventions: Diagnostic Test: Celiac disease antibody screening

• Registration Number: NCT03136731
• Lead Sponsor: Katri Kaukinen

Brief Summary

Main aim: To find evidence-based screening strategies for celiac disease in high risk groups and to find new biomarkers or biomarker combinations for celiac disease diagnostics and follow-up.

Detailed Description

The current project will result in the identification of genetic, environmental or downstream biomedical markers that predict the development of celiac disease at the individual level. Moreover, the markers can be exploited in prediction of specific disease risks, manifestations, comorbidities and complications.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-02
• Study Start: 2017-11-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3517

Inclusion Criteria

• Cohort 1: Family member of celiac disease patient
• Cohort 2: Previously diagnosed celiac disease

Exclusion Criteria

• Cohort 1: No previous celiac disease
• Cohort 2: Celiac disease diagnosis not confirmed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy family members of celiac disease	Celiac disease antibody screening	Celiac disease screening, no intervention.

Primary Outcome Measures

Name	Time	Method
Forthcoming celiac disease diagnosed by current diagnostic criteria	With in 10 years	Assessed by positive transglutaminase antibodies, small bowel mucosal villous atrophy

Trial Locations

Locations (1)

Tampere University Hospital / Tampere University; 🇫🇮 Tampere, Finland