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NCT03136731 Clinical Trial

Evidence-based Screening Strategies for Celiac Disease

Celiac Disease Clinical Trial

Official title:
Improving Case-finding Strategies for Celiac Disease in Family Members: a Follow-up Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03136731
Other study ID # Celiac2017
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 29, 2017
Est. completion date December 31, 2032

Study information
Verified date January 2023
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 3517
Est. completion date December 31, 2032
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Celiac disease antibody screening
Observational parameters

Locations
Country Name City State
Finland Tampere University Hospital / Tampere University Tampere

Sponsors (1)
Lead Sponsor Collaborator
Katri Kaukinen

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Forthcoming celiac disease diagnosed by current diagnostic criteria Assessed by positive transglutaminase antibodies, small bowel mucosal villous atrophy With in 10 years
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