Type 1 DiabetesCASCADENCT04677699
Combined Antibody Screening for Celiac and Diabetes Evaluation
An observational study of Type 1 Diabetes and Celiac Disease, run by Pacific Northwest Research Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 day to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Celiac Disease
- What is being tested?
- Combined Risk Score
- How many people
- 64,410 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns and school aged children in the state of Washington.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Northwest Research Institute
Seattle, Washington, 98122
About this study
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.
- Conditions
- Type 1 Diabetes, Celiac Disease
- Being tested
- Combined Risk Score
- Keywords
- Type 1 Diabetes, Celiac Disease, Diabetes, Celiac, Gluten, Autoantibodies
- Medical subject headings
- Diabetes Mellitus, Type 1, Celiac Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Birth Cohort | Newborns less than 8 months old and born in the state of Washington. Receives: Diagnostic Test: Combined Risk Score | |
| Kids Cohort | Children ages 4-7 years and born in the state of Washington. Receives: Diagnostic Test: Combined Risk Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Type 1 Diabetes
Measured: 5 years
Diagnosis of Celiac Disease
Measured: 5 years
Secondary outcomes (1)
Severity of disease at diagnosis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Northwest Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Principal investigator, William Hagopian, Pacific Northwest Research Institute
- Investigators
- William Hagopian, MD PhD, Principal investigator, Pacific Northwest Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677699
- Sponsor's protocol ID
- WSIRB# 2020-078
- Acronym
- CASCADE
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Antibody Screening for Celiac and Diabetes Evaluation
- ClinicalTrials.gov ID
- NCT04677699
- Acronym / sponsor ID
- CASCADE / WSIRB# 2020-078
- Conditions
- Type 1 Diabetes, Celiac Disease
- Keywords
- Type 1 Diabetes, Celiac Disease, Diabetes, Celiac, Gluten, Autoantibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64,410 participants (estimated)
- Lead sponsor
- Pacific Northwest Research InstituteUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Birth Cohort | – | Diagnostic Test: Combined Risk ScoreNewborns less than 8 months old and born in the state of Washington. |
| Kids Cohort | – | Diagnostic Test: Combined Risk ScoreChildren ages 4-7 years and born in the state of Washington. |
Who may qualify
- Ages
- 1 day to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns and school aged children in the state of Washington.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Risk ScoreSeveral 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. | Diagnostic test | Birth Cohort, Kids Cohort |
Primary outcome
Diagnosis of Type 1 Diabetes
Time frame: 5 years
Diagnosis of Celiac Disease
Time frame: 5 years
1 secondary outcome
Severity of disease at diagnosis
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Hagopian, MD PhD principal investigator
Pacific Northwest Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Celiac Disease, run by Pacific Northwest Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Type 1 Diabetes (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.