NCT02923440 Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways
| NCT ID | NCT02923440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Congenital Heart Defects |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2017-01-17 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2017-01-17 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank
Eligibility Criteria
Inclusion Criteria: * Echocardiographic diagnosis of congenital heart defect falling within the classification Houyel and Bonnet * Necessity of making a blood test regardless of study * Medical care in the AP-HM Timone Hospital children, medical-surgical unit of pediatric and congenital cardiology, Marseille - These Parent Child Exclusion Criteria: * Pregnant women * Patients or parent / legal guardian (if minor) in physical or mental incapacity to understand or sign the consent * People in Emergencies * Persons deprived of freedom * Persons not beneficiaries of a social security scheme * Persons in health or social institution
Contact & Investigator
CAROLINE OVAERT
✉ caroline.ovaert@ap-hm.frcatherine GEINDRE
STUDY DIRECTOR
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
Frequently Asked Questions
Who can join the NCT02923440 clinical trial?
This trial is open to participants of all sexes, studying Congenital Heart Defects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02923440 currently recruiting?
Yes, NCT02923440 is actively recruiting participants. Contact the research team at caroline.ovaert@ap-hm.fr for enrollment information.
Where is the NCT02923440 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT02923440 clinical trial?
NCT02923440 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is catherine GEINDRE at ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE. The trial plans to enroll 300 participants.