FH Detection in Children by Salivary Test

NCT04261803 | Completed

• 2 other identifiers: 69HCL19_08612019-A03076-51
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipoproteinemia Type II

Keywords

familial hypercholesterolemia; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• salivary cholesterol concentration

  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

Study Arms (2)

Familial Hypercholesterolemia children

Biological: salivary sample; Biological: blood test

Control children

Biological: salivary sample; Biological: blood test

Interventions

salivary sample BIOLOGICAL

spit of saliva in a tube

Control children; Familial Hypercholesterolemia children

blood test BIOLOGICAL

2millilitter blood test

Control children; Familial Hypercholesterolemia children

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Familial Hypercholesterolemia children group Control children group

You may qualify if:

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

You may not qualify if:

• poor dental health
• for control patients: to have a known cholesterol disease

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon gastro-enterological hepatology and nutrition

Bron, 69500, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva and blood

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Noel PERETTI, MD

  Hospices Civils de Lyon gastro-enterological hepatology and nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: February 18, 2020
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

FR (1)