School-based Education and Screening Program With Lipid S... | NCT05767996

Studies
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia

NCT05767996

Sponsor

Poudre Valley Health System

Status

Unknown status

Last Update Posted

Apr 3, 2024Actual

Enrollment

104Estimated

Phase

Not provided

Conditions

Familial Hyperlipidemia

Interventions

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

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

Feb 1, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 2, 2023

First Submission Date that Met QC Criteria

Mar 2, 2023

First Posted Date

Mar 14, 2023Actual

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

Apr 1, 2024

Last Update Posted Date

Apr 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gary J. Luckasen, MD, Principal Investigator, University of Colorado HealthPrincipal Investigator

Lead Sponsor

Poudre Valley Health SystemOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.

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

104Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia	Percentage of school children who have elevated cholesterol related to FH variant	Evaluation of family members over a defined 5 year period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elevated cholesterol on baseline screening to use as means of identifying those with an FH variant

Exclusion Criteria:

normal cholesterol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Elementary school children participating in baseline biometric screening, including cholesterol; with those with elevated cholesterol receiving genetic testing to identify presence/absence of FH variant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center of the Rockies		Loveland	Colorado	80538	United States

Type	Date	Date Unknown
Release	Jul 30, 2025
Reset	Aug 14, 2025
Release	Sep 17, 2025
Reset	Oct 9, 2025
Release	Oct 30, 2025
Reset	Nov 13, 2025
Release	Nov 19, 2025
Reset	Dec 2, 2025

Submission Tracking

Estimated Results First Submitted Date

Jul 30, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 30, 2025			Aug 14, 2025
Sep 17, 2025