Celiac DiseaseNCT03136731
Evidence-based Screening Strategies for Celiac Disease
An observational study of Celiac Disease, run by Katri Kaukinen at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Celiac disease antibody screening
- How many people
- 3,517 participants
- Where
- 1 siteFinland
- Study dates
- 29 Nov 2017to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Cohort 1: Family member of celiac disease patient
- Cohort 2: Previously diagnosed celiac disease
Who cannot join
- Cohort 1: No previous celiac disease
- Cohort 2: Celiac disease diagnosis not confirmed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- Celiac disease antibody screening
- Keywords
- Celiac disease, Gluten, Microbiome, Genetic
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celiac disease antibody screeningDiagnostic test
Observational parameters
| Study group | Role | What they receive |
|---|---|---|
| Healthy family members of celiac disease | Celiac disease screening, no intervention. Receives: Diagnostic Test: Celiac disease antibody screening | |
| Celiac disease index cases | Assessment of disease related factors, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forthcoming celiac disease diagnosed by current diagnostic criteria
Assessed by positive transglutaminase antibodies, small bowel mucosal villous atrophy
Measured: With in 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start29 Nov 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,517 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katri Kaukinen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katri Kaukinen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136731
- Sponsor's protocol ID
- Celiac2017
- Status last verified
- Jan 2023
- First submitted
- 30 Mar 2017
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35611878Paavola 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.
PubMed 34278595
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Case-finding Strategies for Celiac Disease in Family Members: a Follow-up Study
- ClinicalTrials.gov ID
- NCT03136731
- Acronym / sponsor ID
- Celiac2017
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Gluten, Microbiome, Genetic
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,517 participants (estimated)
- Lead sponsor
- Katri KaukinenUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy family members of celiac disease | – | Diagnostic Test: Celiac disease antibody screeningCeliac disease screening, no intervention. |
| Celiac disease index cases | – | –Assessment of disease related factors, no intervention. |
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Cohort 1: Family member of celiac disease patient
- Cohort 2: Previously diagnosed celiac disease
Key exclusion criteria (2 listed)
- Cohort 1: No previous celiac disease
- Cohort 2: Celiac disease diagnosis not confirmed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celiac disease antibody screeningObservational parameters | Diagnostic test | Healthy family members of celiac disease |
Primary outcome
Forthcoming celiac disease diagnosed by current diagnostic criteria
Time frame: With in 10 years
Assessed by positive transglutaminase antibodies, small bowel mucosal villous atrophy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 35611878Paavola 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.
- Derived from this study: PubMed 34278595Paavola 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Katri Kaukinen at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forthcoming celiac disease diagnosed by current diagnostic criteria (time frame: With in 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136731, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.