FH Detection in Children by Salivary Test (DEPEDIACOL)

September 4, 2020 updated by: Hospices Civils de Lyon

Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hospices Civils de Lyon gastro-enterological hepatology and nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Familial Hypercholesterolemia children group Control children group

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control children
Biological: salivary sample
spit of saliva in a tube
Biological: blood test
2millilitter blood test
Familial Hypercholesterolemia children
Biological: salivary sample
spit of saliva in a tube
Biological: blood test
2millilitter blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
salivary cholesterol concentration
Time Frame: Day 1
the 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Noel PERETTI, MD, Hospices Civils de Lyon gastro-enterological hepatology and nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 18, 2020

Primary Completion (ACTUAL)

August 26, 2020

Study Completion (ACTUAL)

August 26, 2020

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (ACTUAL)

February 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0861
  • 2019-A03076-51 (OTHER: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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