Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease
NCT ID: NCT06849622
Last Updated: 2025-02-27
Study Results
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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RECRUITING
NA
1500 participants
INTERVENTIONAL
2024-11-04
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Test on blood sample (diagnosis of celiac and diabetes disease)
Test on blood sample
The blood sample will be drawn by venipuncture during clinical routine. The serum will be tested for coeliac or diabetes 1 auto-antibodies, using Elisa test.
test on dried blood spot (celiac and diabetes patients)
Test on dried blood sample
A finger prick will be used to collect Dried blood Spot (DBS) on a special card. The eluted blood spot will be tested, for coeliac and diabetes 1 auto-antibodies, using the same method used for serum, and the same cut-offs for positivity and negativity (Elisa tests)
Interventions
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Test on blood sample
The blood sample will be drawn by venipuncture during clinical routine. The serum will be tested for coeliac or diabetes 1 auto-antibodies, using Elisa test.
Test on dried blood sample
A finger prick will be used to collect Dried blood Spot (DBS) on a special card. The eluted blood spot will be tested, for coeliac and diabetes 1 auto-antibodies, using the same method used for serum, and the same cut-offs for positivity and negativity (Elisa tests)
Eligibility Criteria
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Inclusion Criteria
* Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls)
* Obtained informed consent
Exclusion Criteria
2 Years
13 Years
ALL
No
Sponsors
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Meyer Children's Hospital IRCCS
OTHER
Responsible Party
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Locations
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Meyer Children's Hospital IRCCS
Florence, Italy, Italy
Countries
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Central Contacts
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Other Identifiers
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CELDI
Identifier Type: -
Identifier Source: org_study_id
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