Screening for Hypercholesterolemia in Children Using Dried Blood Spot

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05191355

Acronym

CHOLESPOT

Enrollment

Registered

2022-01-13

Start date

2022-05-18

Completion date

2023-02-28

Last updated

2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia, Familial, Pediatrics

Brief 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

Interventions

BIOLOGICALblood test

Blood spot collection for sampling

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026