NCT03136731

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,517

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Nov 2017Dec 2032

First Submitted

Initial submission to the registry

March 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Expected
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

6.1 years

First QC Date

March 30, 2017

Last Update Submit

January 18, 2023

Conditions

Keywords

Celiac disease, Gluten, Microbiome, Genetic

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.

Diagnostic Test: Celiac disease antibody screening

Celiac disease index cases

Assessment of disease related factors, no intervention.

Interventions

Observational parameters

Healthy family members of celiac disease

Eligibility Criteria

Age6 Months - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Study Sites (1)

Tampere University Hospital / Tampere University

Tampere, 33521, Finland

Location

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.

  • 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.

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

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

Locations