Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT04261803
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FH Detection in Children by Salivary Test
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEPEDIACOL
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.
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A03076-51 | OTHER | ID-RCB | View |