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Combined Antibody Screening for Celiac and Diabetes Evaluation

NCT ID: NCT04677699

Last Updated: 2020-12-21

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

64410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-31

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Celiac Disease

Keywords

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Type 1 Diabetes Celiac Disease Diabetes Celiac Gluten Autoantibodies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Birth Cohort

Newborns less than 8 months old and born in the state of Washington.

Combined Risk Score

Intervention Type DIAGNOSTIC_TEST

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.

Kids Cohort

Children ages 4-7 years and born in the state of Washington.

Combined Risk Score

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

\-
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Exeter

OTHER

Sponsor Role collaborator

Pacific Northwest Research Institute

OTHER

Sponsor Role lead

Responsible Party

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William Hagopian

Director of Diabetes Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Hagopian, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Pacific Northwest Research Institute

Locations

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Pacific Northwest Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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WSIRB# 2020-078

Identifier Type: -

Identifier Source: org_study_id