From Known to New Genes in Dyslipidemia

Dyslipidemias Clinical Trial

— GENELIP  

Official title:

Genetical Characterization of Patients Presenting With Dyslipidemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03939039
• Other study ID #: GENELIP
• Status: Recruiting
• Start date: January 1, 2000
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: Mathilde Di Filippo
• Phone: 4 72 11 89 94
• Email: mathilde.di-filippo[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The mechanism of the majority of the dyslipidemia is multifactorial at the molecular level and remains elusive in more than 50% of the patients in many clinical conditions. Next generation sequencing, a booming strategy, improves the molecular diagnosis efficiency in both monogenic and polygenic dyslipidemia.

In order to decipher the mechanisms involved in the occurrence of dyslipidemia, in addition to the exploration of known candidate genes and Single Nucleotide Polymorphisms (SNP) involved in polygenic modulation, new genes involved in the regulation of lipoprotein metabolism or associated with lipids concentrations need to be sequenced in large groups of dyslipidemic patients.

The goal of this project is to gain new insight into genotype/phenotype correlation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with a family documented history of primary hypercholesterolemia, hypertriglyceridemia, hypobetalipoproteinemia, combined hypolipidemia and combined hyperlipidemia according to the European Atherosclerosis Society and/or published data.

• patients with major secondary dyslipidemia.

Exclusion Criteria:

• inability to provide written informed consent

• lack of legal representative

Related Conditions & MeSH terms

• Dyslipidemias

Locations

Country	Name	City	State
France	Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est, Département de biochimie et biologie moléculaire Grand Est	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetical exploration in dyslipidemic patients	Deoxyribonucleic Acid (DNA) sequencing will allow the study of rare gene variants and their frequency in known and new genes in patients with dyslipidemia.	25 years