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NCT06849622 | RECRUITING | Celiac Disease in Children


Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease
Sponsor:

Meyer Children's Hospital IRCCS

Brief Summary:

Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.

Condition or disease

Celiac Disease in Children

Diabetes Mellitus, Type I

Screening

Intervention/treatment

Test on blood sample

Test on dried blood sample

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 1500 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease
Actual Study Start Date : 2024-11-04
Estimated Primary Completion Date : 2026-03-30
Estimated Study Completion Date : 2026-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 2 Years to 13 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients aged 2-13 years
  • * 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
  • * none

Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease

Location Details

NCT06849622


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Locations


RECRUITING

Italy, Italy

Meyer Children's Hospital IRCCS

Florence, Italy, Italy, 50139

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