FH Detection in Children by Salivary Test

NCT ID: NCT04261803

Last Updated: 2020-09-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-18

Study Completion Date

2020-08-26

Brief Summary

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Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines.

International studies show treatment must be initiated early as at the age of eight years old.

In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test.

The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.

Detailed Description

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Conditions

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Hyperlipoproteinemia Type II

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Familial Hypercholesterolemia children

salivary sample

Intervention Type BIOLOGICAL

spit of saliva in a tube

blood test

Intervention Type BIOLOGICAL

2millilitter blood test

Control children

salivary sample

Intervention Type BIOLOGICAL

spit of saliva in a tube

blood test

Intervention Type BIOLOGICAL

2millilitter blood test

Interventions

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salivary sample

spit of saliva in a tube

Intervention Type BIOLOGICAL

blood test

2millilitter blood test

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* children under 18 years old, with familial hypercholesterolemia
* children under 18 years old, intending surgery
* being able to spit

Exclusion Criteria

* poor dental health
* for control patients: to have a known cholesterol disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noel PERETTI, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon gastro-enterological hepatology and nutrition

Locations

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Hospices Civils de Lyon gastro-enterological hepatology and nutrition

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2019-A03076-51

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0861

Identifier Type: -

Identifier Source: org_study_id

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