Evidence-based Screening Strategies for Celiac Disease

January 18, 2023 updated by: Katri Kaukinen

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital / Tampere University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy family members of celiac disease
Celiac disease screening, no intervention.
Diagnostic test: Celiac disease antibody screening
Observational parameters
Celiac disease index cases
Assessment of disease related factors, no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forthcoming celiac disease diagnosed by current diagnostic criteria
Time Frame: With in 10 years
Assessed by positive transglutaminase antibodies, small bowel mucosal villous atrophy
With in 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katri Kaukinen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2017

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2032

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Celiac2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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