HypercholesterolemiaCHOLESPOTNCT05191355
Screening for Hypercholesterolemia in Children Using Dried Blood Spot
An observational study of Hypercholesterolemia, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Purpose: Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- blood test
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 18 May 2022to 28 Feb 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adults with heterozygous familial hypercholesterolemia and healthy subjects
Who may be able to join
- patients/kindreds in family with a documented history of hypercholesterolemia
- healthy subjects for controls
Who cannot join
- refusal to participate in the study
- For control patients: to have a known dyslipidemia
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon, Dept of Endocrinology
Bron, 69500
Hospices Civils de Lyon, Service d'Hépatologie et de Gastro-Entérologie et Nutrition Pédiatrique
Bron, 69500
About this study
Official title: Screening for Familial Hypercholesterolemia in Children Using the Blotter Method, or Dried Blood Spot
Purpose:
Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia.
Read more
Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture.
The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement
Hypothesis
- to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia
- to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Being tested
- blood test
- Keywords
- Hypercholesterolemia, Familial, Pediatrics
- Medical subject headings
- Hypercholesterolemia, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testBiological
Blood spot collection for sampling
| Study group | Role | What they receive |
|---|---|---|
| subjects with familial hypercholesterolemia | blood test Receives: Biological: blood test | |
| healthy subjects | blood test Receives: Biological: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling
study of the feasibility and accuracy of the blotter method to screen hypercholesterolemia
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start18 May 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Case-control
- 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
- Noël PERETTI, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191355
- Sponsor's protocol ID
- 69HCL21_0178
- Other IDs
- 2021-A02907-34
- Acronym
- CHOLESPOT
- Status last verified
- Aug 2023
- First submitted
- 30 Dec 2021
- Last updated
- 1 Sep 2023
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Familial Hypercholesterolemia in Children Using the Blotter Method, or Dried Blood Spot
- ClinicalTrials.gov ID
- NCT05191355
- Acronym / sponsor ID
- CHOLESPOT / 69HCL21_0178
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Familial, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 13 Jan 2022 (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.
Purpose:
Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia.
Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture.
The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement
Hypothesis
- to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia
- to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with familial hypercholesterolemia | – | Biological: blood testblood test |
| healthy subjects | – | Biological: blood testblood test |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults with heterozygous familial hypercholesterolemia and healthy subjects
Key inclusion criteria (2 listed)
- patients/kindreds in family with a documented history of hypercholesterolemia
- healthy subjects for controls
Key exclusion criteria (2 listed)
- refusal to participate in the study
- For control patients: to have a known dyslipidemia
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 |
|---|---|---|
| blood testBlood spot collection for sampling | Biological | healthy subjects, subjects with familial hypercholesterolemia |
Primary outcome
Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling
Time frame: Day 0
study of the feasibility and accuracy of the blotter method to screen hypercholesterolemia
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 1 Sep 2023.
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A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
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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.
Noël PERETTI, MD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Hospices Civils de Lyon at 2 sites 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 2 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling (time frame: Day 0). 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 1 Sep 2023.