NCT05271305

Brief Summary

A pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school. The pilot study shall evaluate whether this screening set-up is efficient to detect patients having familial hypercholesterolemia, detect further patients by an adjacent cascade screening of family members, to deliver treatment to these patients and to provide this screening in a cost-effective manner.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 4, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

February 23, 2022

Last Update Submit

March 4, 2022

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • familial hypercholesteromia

    percentage of screened primary school children with hypercholesterolemia

    2021-2024

Secondary Outcomes (2)

  • percentage of children screened

    2021-2024

  • percentage of families screened

    2021-2024

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children, invited for their medical check through school medicine unit of the city of luxembourg, are invited to participate

You may qualify if:

  • \. Attending primary school in the city of Luxembourg and invited for the legal medical visit

You may not qualify if:

  • \. No parental informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHde Luxembourg

Luxembourg, 1210, Luxembourg

Location

Related Publications (1)

  • Becker M, Adamski A, Fandel F, Vaillant M, Wagner K, Droste DW, Ziade B, Hein S, Mendon P, Bocquet V, de Beaufort C. Screening for familial hypercholesterolaemia in primary school children: protocol for a cross-sectional, feasibility study in Luxembourg city (EARLIE). BMJ Open. 2022 Dec 9;12(12):e066067. doi: 10.1136/bmjopen-2022-066067.

    PMID: 36600332DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Carine de Beaufort, MPhD

    CHL

    PRINCIPAL INVESTIGATOR

  • Marianne Becker, MD

    CHL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor pediatrics

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 9, 2022

Study Start

September 4, 2021

Primary Completion

July 30, 2023

Study Completion

December 31, 2023

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

LU(1)