Familial HypercholesterolemiaEARLIENCT05271305
Pilot Study for a National Screening for Familial Hypercholesterolemia
An observational study of Familial Hypercholesterolemia, run by Centre Hospitalier du Luxembourg at 1 site in Luxembourg.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Hypercholesterolemia
- How many people
- 2,000 participants
- Where
- 1 siteLuxembourg
- Study dates
- 4 Sep 2021to 31 Dec 2023
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All children, invited for their medical check through school medicine unit of the city of luxembourg, are invited to participate
Who may be able to join
- 1. Attending primary school in the city of Luxembourg and invited for the legal medical visit
Who cannot join
- 1. No parental informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Familial Hypercholesterolemia
- Medical subject headings
- Hyperlipoproteinemia Type II
What is being measured
The primary outcome is the main question the study is designed to answer.
familial hypercholesteromia
percentage of screened primary school children with hypercholesterolemia
Measured: 2021-2024
Secondary outcomes (2)
percentage of children screened
number screened/number invited
Measured: 2021-2024
percentage of families screened
index case family screening
Measured: 2021-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start4 Sep 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies 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
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Luxembourg
- Sponsor type
- University, hospital or other
- Collaborators
- Luxembourg Institute of Health
- Responsible party
- Principal investigator, Carine de Beaufort, Centre Hospitalier du Luxembourg
- Investigators
- Carine de Beaufort, MPhD, Principal investigator, Croatian Hypertension LeagueMarianne Becker, MD, Principal investigator, Croatian Hypertension League
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271305
- Sponsor's protocol ID
- FHC
- Acronym
- EARLIE
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36600332
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for a National Screening for Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05271305
- Acronym / sponsor ID
- EARLIE / FHC
- Conditions
- Familial Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier du LuxembourgUniversity, hospital or other
- Collaborators
- Luxembourg Institute of Health
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Mar 2022 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All children, invited for their medical check through school medicine unit of the city of luxembourg, are invited to participate
Key inclusion criteria (1 listed)
- 1. Attending primary school in the city of Luxembourg and invited for the legal medical visit
Key exclusion criteria (1 listed)
- 1. No parental informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
familial hypercholesteromia
Time frame: 2021-2024
percentage of screened primary school children with hypercholesterolemia
2 secondary outcomes
percentage of children screened
Time frame: 2021-2024
percentage of families screened
Time frame: 2021-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 36600332Becker 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.
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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.
Carine de Beaufort, MPhD principal investigator
Croatian Hypertension League
Marianne Becker, MD principal investigator
Croatian Hypertension League
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 Familial Hypercholesterolemia, run by Centre Hospitalier du Luxembourg at 1 site in Luxembourg.
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 9 Mar 2022. 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 Luxembourg. 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?
familial hypercholesteromia (time frame: 2021-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05271305, which also lists 1 linked publication.
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 9 Mar 2022.