NCT04677699

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64,410

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 16, 2020

Last Update Submit

December 16, 2020

Conditions

Keywords

Type 1 DiabetesCeliac DiseaseDiabetesCeliacGlutenAutoantibodies

Outcome Measures

Primary Outcomes (2)

  • Diagnosis of Type 1 Diabetes

    5 years

  • Diagnosis of Celiac Disease

    5 years

Secondary Outcomes (1)

  • Severity of disease at diagnosis

    5 years

Study Arms (2)

Birth Cohort

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

Diagnostic Test: Combined Risk Score

Kids Cohort

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

Diagnostic Test: Combined Risk Score

Interventions

Combined Risk ScoreDIAGNOSTIC_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.

Birth CohortKids Cohort

Eligibility Criteria

Age1 Day - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborns and school aged children in the state of Washington.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Northwest Research Institute

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Celiac DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • William Hagopian, MD PhD

    Pacific Northwest Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Diabetes Program

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 21, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion (Estimated)

June 1, 2026

Last Updated

December 21, 2020

Record last verified: 2020-12

Locations