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NCT04677699 Clinical Trial

Combined Antibody Screening for Celiac and Diabetes Evaluation

Type 1 Diabetes Clinical Trial

— CASCADE  

Official title:
Combined Antibody Screening for Celiac and Diabetes Evaluation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04677699
Other study ID # WSIRB# 2020-078
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 2020
Est. completion date June 2026

Study information
Verified date December 2020
Source Pacific Northwest Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The CASCADE Study (Combined Antibody Screening for Celiac and Diabetes Evaluation) is an observational study whose primary goal is to show that population-based screening for advanced prediction of type 1 diabetes (T1D) and celiac disease (CD) is feasible to prevent diabetic ketoacidosis (DKA), improve celiac disease diagnosis, and ultimately gain public health acceptance to facilitate future prevention. It has two arms, a Birth Cohort and a Kids (cross sectional) Cohort.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 64410
Est. completion date June 2026
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 7 Years
Eligibility Inclusion Criteria: - Child must be between 0 to 8 months in age or between 4 to 7 years in age. Child must be born in the state of Washington. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Combined Risk Score
Several factors will be analyzed to assign each subject combined risk score. This will assess the subject's risk of developing Type 1 Diabetes and/or Celiac Disease.

Locations
Country Name City State
United States Pacific Northwest Research Institute Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
Pacific Northwest Research Institute University of Exeter

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosis of Type 1 Diabetes 5 years
Primary Diagnosis of Celiac Disease 5 years
Secondary Severity of disease at diagnosis 5 years
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