Hyperlipoproteinemia Type IIDEPEDIACOLNCT04261803
FH Detection in Children by Salivary Test
An observational study of Hyperlipoproteinemia Type II, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipoproteinemia Type II
- What is being tested?
- salivary sample and blood test
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2020to 26 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Familial Hypercholesterolemia children group Control children group
Who may be able to join
- children under 18 years old, with familial hypercholesterolemia
- children under 18 years old, intending surgery
- being able to spit
Who cannot join
- poor dental health
- for control patients: to have a known cholesterol disease
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon gastro-enterological hepatology and nutrition
Bron, 69500
About this study
Official title: 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.
Read more
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
- Being tested
- salivary sample, blood test
- Keywords
- familial hypercholesterolemia, Healthy Volunteers
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivary sampleBiological
spit of saliva in a tube
blood testBiological
2millilitter blood test
| Study group | Role | What they receive |
|---|---|---|
| Familial Hypercholesterolemia children | Not described Receives: Biological: salivary sample; Biological: blood test | |
| Control children | Not described Receives: Biological: salivary sample; Biological: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start18 Feb 2020
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipoproteinemia Type IIStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel PERETTI, MD, Principal investigator, Hospices Civils de Lyon gastro-enterological hepatology and nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261803
- Sponsor's protocol ID
- 69HCL19_0861
- Other IDs
- 2019-A03076-51
- Acronym
- DEPEDIACOL
- Status last verified
- Sep 2020
- First submitted
- 6 Feb 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test
- ClinicalTrials.gov ID
- NCT04261803
- Acronym / sponsor ID
- DEPEDIACOL / 69HCL19_0861
- Conditions
- Hyperlipoproteinemia Type II
- Keywords
- familial hypercholesterolemia, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familial Hypercholesterolemia children | – | Biological: salivary sample, Biological: blood test |
| Control children | – | Biological: salivary sample, Biological: blood test |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Familial Hypercholesterolemia children group Control children group
Key inclusion criteria (3 listed)
- children under 18 years old, with familial hypercholesterolemia
- children under 18 years old, intending surgery
- being able to spit
Key exclusion criteria (2 listed)
- poor dental health
- for control patients: to have a known cholesterol disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salivary samplespit of saliva in a tube | Biological | Control children, Familial Hypercholesterolemia children |
| blood test2millilitter blood test | Biological | Control children, Familial Hypercholesterolemia children |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
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Truway Diagnostic Tools in Primary Care
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An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
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Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel PERETTI, MD principal investigator
Hospices Civils de Lyon gastro-enterological hepatology and nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipoproteinemia Type II, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary cholesterol concentration (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.