Screening for Hypercholesterolemia in Children Using Dried Blood Spot
NCT ID: NCT05191355
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2022-05-18
2023-02-28
Brief Summary
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Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia.
Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture.
The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement
Hypothesis
* to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia
* to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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subjects with familial hypercholesterolemia
blood test
blood test
Blood spot collection for sampling
healthy subjects
blood test
blood test
Blood spot collection for sampling
Interventions
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blood test
Blood spot collection for sampling
Eligibility Criteria
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Inclusion Criteria
* healthy subjects for controls
Exclusion Criteria
* For control patients: to have a known dyslipidemia
2 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Noël PERETTI, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hospices Civils de Lyon, Dept of Endocrinology
Bron, , France
Hospices Civils de Lyon, Service d'Hépatologie et de Gastro-Entérologie et Nutrition Pédiatrique
Bron, , France
Countries
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Other Identifiers
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2021-A02907-34
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL21_0178
Identifier Type: -
Identifier Source: org_study_id
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