Combined Antibody Screening for Celiac and Diabetes Evalu... | NCT04677699

Studies
Combined Antibody Screening for Celiac and Diabetes Evaluation

NCT04677699

Sponsor

Pacific Northwest Research Institute

Status

Unknown status

Last Update Posted

Dec 21, 2020Actual

Enrollment

64,410Estimated

Phase

Not provided

Conditions

Type 1 Diabetes
Celiac Disease

Interventions

Combined Risk Score

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2020Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Dec 16, 2020

First Submission Date that Met QC Criteria

Dec 16, 2020

First Posted Date

Dec 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2020

Last Update Posted Date

Dec 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Hagopian, Director of Diabetes Program, Pacific Northwest Research InstitutePrincipal Investigator

Lead Sponsor

Pacific Northwest Research InstituteOTHER

Collaborators

Name	Class
University of Exeter	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64,410Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Combined Risk Score	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of Type 1 Diabetes		5 years
Diagnosis of Celiac Disease		5 years

Secondary Outcomes

Measure	Description	Time Frame
Severity of disease at diagnosis		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

7 Years

Standard Ages

Child

Study Population

Newborns and school aged children in the state of Washington.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Hagopian, MD PhD	Pacific Northwest Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Northwest Research Institute		Seattle	Washington	98122	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D002446	Celiac Disease
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided