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EARLIE: Pilot Study for a National Screening for Familial Hypercholesterolemia

Sponsor
Centre Hospitalier du Luxembourg (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05271305
Collaborator
Luxembourg Institute of Health (Other)
2,000
Enrollment
1
Location
27.9
Anticipated Duration (Months)
71.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Pilot Study for a National Screening for Familial Hypercholesterolemia
    Actual Study Start Date :
    Sep 4, 2021
    Anticipated Primary Completion Date :
    Jul 30, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. familial hypercholesteromia [2021-2024]

      percentage of screened primary school children with hypercholesterolemia

    Secondary Outcome Measures

    1. percentage of children screened [2021-2024]

      number screened/number invited

    2. percentage of families screened [2021-2024]

      index case family screening

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHde Luxembourg Luxembourg Luxembourg 1210

    Sponsors and Collaborators

    • Centre Hospitalier du Luxembourg
    • Luxembourg Institute of Health

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carine de Beaufort, professor pediatrics, Centre Hospitalier du Luxembourg
    ClinicalTrials.gov Identifier:
    NCT05271305
    Other Study ID Numbers:
    • FHC
    First Posted:
    Mar 9, 2022
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type II
    Hypercholesterolemia

    Study Results

    No Results Posted as of Mar 9, 2022