Actively Recruiting
Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways
Led by Assistance Publique Hopitaux De Marseille · Updated on 2023-03-13
300
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Congenital heart defects affect about 0.8% of live births, with over 5,000 newborns affected annually in France. The south-east region of France has a higher rate of these defects due to increased birth rates and consanguinity. While genetic causes are important, they are not well understood, and large-scale DNA collections with detailed disease classification are needed to improve knowledge. Currently, such a DNA bank exists in Paris but not in the south-east region. This research aims to create a local database and DNA bank named SEA-HD in the south-east of France to collect biological samples and detailed clinical information on congenital heart defects. The study involves collecting blood samples from patients diagnosed by echocardiography using a specific classification system. This setup allows local genetic analysis and storage without the high costs of transporting samples to Paris. Participants will undergo blood tests as part of their care at the AP-HM Timone Hospital pediatric cardiology unit in Marseille. Researchers will track the number of patients with congenital heart defects over three years. The study includes genetic sample collection, medical evaluations, and long-term monitoring of patients' health and genetic data. The trial aims to enhance understanding of genetic pathways in congenital heart disease through this regional database and biobank.
CONDITIONS
Brief Title
Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Echocardiographic diagnosis of congenital heart defect according to the Houyel and Bonnet classification
- Need for a blood test regardless of study participation
- Receiving medical care at AP-HM Timone Hospital pediatric and congenital cardiology unit, Marseille
You will not qualify if you...
- Pregnant women
- Individuals or legal guardians unable to understand or sign consent
- Emergency patients
- Persons deprived of freedom
- Persons without social security coverage
- Persons in health or social institutions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo blood sample collection to assist in the diagnosis and exploration of genetic pathways related to congenital heart defects.
1 visit (in-person) for blood sample collection
Duration - Up to 3 years
Participants are monitored over time to observe the presence and progression of congenital heart defects.
Follow-up visits as part of routine medical care
Trial Site Locations
Total: 1 location
1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Actively Recruiting
Research Team
C
CAROLINE OVAERT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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