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FH Detection in Children by Salivary Test

Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04261803
Acronym
DEPEDIACOL
Enrollment
60
Registered
2020-02-10
Start date
2020-02-18
Completion date
2020-08-26
Last updated
2020-09-07

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

Conditions

Hyperlipoproteinemia Type II

Keywords

familial hypercholesterolemia, Healthy Volunteers

Brief summary

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.

Interventions

BIOLOGICALsalivary sample

spit of saliva in a tube

BIOLOGICALblood test

2millilitter blood test

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
salivary cholesterol concentrationDay 1the sample will be obtained during one visit non dedicated to this study (following-visit in nutrition for hypercholesterolemia children and before surgery for control children), the swabs of all the 60 patients will be used in two different methods of enzymatic tests.

Countries

France

Outcome results

None listed

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