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FH Detection in Children by Salivary Test (DEPEDIACOL)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Hyperlipoproteinemia Type II

Treatments

Biological: salivary sample
Biological: blood test

Study type

Observational

Funder types

Other

Identifiers

NCT04261803
2019-A03076-51 (Other Identifier)
69HCL19_0861

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 2 patient groups

Familial Hypercholesterolemia children
Treatment:
Biological: blood test
Biological: salivary sample
Control children
Treatment:
Biological: blood test
Biological: salivary sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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