Evidence-based Screening Strategies for Celiac Disease

NCT ID: NCT03136731

Last Updated: 2023-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

3517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-29

Study Completion Date

2032-12-31

Brief Summary

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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

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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.

Conditions

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Celiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy family members of celiac disease

Celiac disease screening, no intervention.

Celiac disease antibody screening

Intervention Type DIAGNOSTIC_TEST

Observational parameters

Celiac disease index cases

Assessment of disease related factors, no intervention.

No interventions assigned to this group

Interventions

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Celiac disease antibody screening

Observational parameters

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Katri Kaukinen

OTHER

Sponsor Role lead

Responsible Party

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Katri Kaukinen

Professor, MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tampere University Hospital / Tampere University

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 35611878 (View on PubMed)

Paavola 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.

Reference Type DERIVED
PMID: 34278595 (View on PubMed)

Other Identifiers

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Celiac2017

Identifier Type: -

Identifier Source: org_study_id

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