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NCT05191355 Clinical Trial

Screening for Hypercholesterolemia in Children Using Dried Blood Spot

Hypercholesterolemia Clinical Trial

— CHOLESPOT  

Official title:
Screening for Familial Hypercholesterolemia in Children Using the Blotter Method, or Dried Blood Spot

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05191355
Other study ID # 69HCL21_0178
Secondary ID 2021-A02907-34
Status Completed
Phase
First received
Last updated
Start date May 18, 2022
Est. completion date February 28, 2023

Study information
Verified date August 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose: 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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: - patients/kindreds in family with a documented history of hypercholesterolemia - healthy subjects for controls Exclusion Criteria: - refusal to participate in the study - For control patients: to have a known dyslipidemia

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• blood test
Blood spot collection for sampling

Locations
Country Name City State
France Hospices Civils de Lyon, Dept of Endocrinology Bron
France Hospices Civils de Lyon, Service d'Hépatologie et de Gastro-Entérologie et Nutrition Pédiatrique Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling study of the feasibility and accuracy of the blotter method to screen hypercholesterolemia Day 0
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