Evidence-based Screening Strategies for Celiac Disease

Sponsor

Katri Kaukinen (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03136731

Collaborator

(none)

3,517

Enrollment

Location

181.1

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease	Diagnostic Test: Celiac disease antibody screening

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 Design

Study Type:

Observational

Anticipated Enrollment :

3517 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 29, 2017

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2032

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital / Tampere University	Tampere		Finland	33521

Sponsors and Collaborators

Katri Kaukinen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katri Kaukinen, Professor, MD PhD, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT03136731

Other Study ID Numbers:

Celiac2017

First Posted:

May 2, 2017

Last Update Posted:

Oct 18, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Katri Kaukinen, Professor, MD PhD, Tampere University Hospital

Celiac disease, Gluten, Microbiome, Genetic

Additional relevant MeSH terms:

Celiac Disease

Antibodies

Study Results

No Results Posted as of Oct 18, 2021