Pilot Study for a National Screening for Familial Hypercholesterolemia (EARLIE)

March 4, 2022 updated by: Carine de Beaufort, Centre Hospitalier du Luxembourg

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Pilot study evaluating the feasibility of a screening for familial hypercholesterolemia.

Cross-sectional design. Primary outcome Percentage of screened school children with confirmed familial hypercholesterolemia Participants All children, who attend a public primary school in the city of Luxembourg and are enrolled in the cycle C2.2 (age of 7-8 years; 3rd medical visit at school), cycle C3.2 (age 9-10 years, 4th medical visit at school) and cycle 4.2 (age 11-12 years, 5th medical visit at school) will be invited to participate. Expected number of invited children is around 1600 children/year.

Recruitment will take place during the school year 2021/2022 and 2022/2023. The parents/caregivers of these children will receive written information about the screening. They will receive as well a questionnaire on the family history of premature cardiovascular events and known FHC disease.

Without informed consent, the child cannot be included in the screening program.

All children with signed informed consent will have a finger prick for a capillary blood test in the setting of their medical school exam by an external study nurse (not the school nurse) All data (pseudonymised) on each participant will be entered in the online data base for further analysis.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • CHde Luxembourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. No parental informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
familial hypercholesteromia
Time Frame: 2021-2024
percentage of screened primary school children with hypercholesterolemia
2021-2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of children screened
Time Frame: 2021-2024
number screened/number invited
2021-2024
percentage of families screened
Time Frame: 2021-2024
index case family screening
2021-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier du Luxembourg

Collaborators

Luxembourg Institute of Health

Investigators

  • Principal Investigator: Carine de Beaufort, MPhD, CHL
  • Principal Investigator: Marianne Becker, MD, CHL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2021

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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