Evidence-based Screening Strategies for Celiac Disease
Improving Case-finding Strategies for Celiac Disease in Family Members: a Follow-up Study
1 other identifier
observational
3,517
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedStudy Start
First participant enrolled
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
ExpectedJanuary 19, 2023
January 1, 2023
6.1 years
March 30, 2017
January 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forthcoming celiac disease diagnosed by current diagnostic criteria
Assessed by positive transglutaminase antibodies, small bowel mucosal villous atrophy
With in 10 years
Study Arms (2)
Healthy family members of celiac disease
Celiac disease screening, no intervention.
Celiac disease index cases
Assessment of disease related factors, no intervention.
Interventions
Observational parameters
Eligibility Criteria
Volunteers; cohort 1, 3217 genetically predisposed healthy family members of celiac disease patients (high risk group for celiac disease), Cohort 2, 200 new celiac disease index cases will be enrolled
You may qualify if:
- Cohort 1: Family member of celiac disease patient
- Cohort 2: Previously diagnosed celiac disease
You may not qualify if:
- Cohort 1: No previous celiac disease
- Cohort 2: Celiac disease diagnosis not confirmed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Katri Kaukinenlead
Study Sites (1)
Tampere University Hospital / Tampere University
Tampere, 33521, Finland
Related Publications (2)
Paavola S, Kurppa K, Huhtala H, Saavalainen P, Lindfors K, Kaukinen K. Coeliac disease re-screening among once seronegative at-risk relatives: A long-term follow-up study. United European Gastroenterol J. 2022 Jul;10(6):585-593. doi: 10.1002/ueg2.12255. Epub 2022 May 25.
PMID: 35611878DERIVEDPaavola S, Lindfors K, Kivela L, Cerqueira J, Huhtala H, Saavalainen P, Tauschi R, Kaukinen K, Kurppa K. Presence of high-risk HLA genotype is the most important individual risk factor for coeliac disease among at-risk relatives. Aliment Pharmacol Ther. 2021 Sep;54(6):805-813. doi: 10.1111/apt.16534. Epub 2021 Jul 18.
PMID: 34278595DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD PhD
Study Record Dates
First Submitted
March 30, 2017
First Posted
May 2, 2017
Study Start
November 29, 2017
Primary Completion
December 31, 2023
Study Completion (Estimated)
December 31, 2032
Last Updated
January 19, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share