Clinical Trials in France / NCT05976841
Active, not recruiting
Observational
SEDVasc (RaDiCo Cohort) (RaDiCo-SEDVasc)
NCT05976841 · tracked via the Priya Life Science France tracker
Condition(s) studied
Ehlers-Danlos Syndrome, Vascular Type
Study summary
The goal of this observational study is to describe the natural course of vascular Ehlers-Danlos syndrome, in particular the order of appearance of different types of complications (arterial, digestive, pulmonary and uterine).
Eligibility
Inclusion Criteria:
Patients eligible for inclusion in this study have to fulfil all of the following criteria:
* Patients (adults and children) with genetically-proven vEDS (presence of a pathogenic mutation at the COL3A1 gene);
* Patients (or his/her legal guardian) who does not oppose to his/her personal data collection.
There are no exclusion criteria for this study.
Primary outcome measure(s)
- Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on anatomical criteria (number and type of arterial lesions or angioscanner or MRI) — Through study completion, an average of 3 years
- Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on functional criteria (spontaneous arterial, digestive, obstetrical and pulmonary events) — Through study completion, an average of 3 years
- Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on surgical criteria (types and complications) — Through study completion, an average of 3 years
- Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on evaluation of the quality of life (impact on daily life, social life and professional activity) — Through study completion, an average of 3 years
- Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on evaluation of mortality (death, disability) — Through study completion, an average of 3 years
- Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on the presence of complications at delivery or after C-section — Through study completion, an average of 3 years
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier Universitaire Angers | Angers | France | |
| Hôpital Saint-André | Bordeaux | France | |
| Hôpital de la Cavale Blanche | Brest | France | |
| Hôpital Côte de Nacre | Caen | France | |
| Hôpital Gabriel Montpied | Clermont-Ferrand | France | |
| Hôpital Michallon | Grenoble | France | |
| Hôpital Claude Huriez | Lille | France | |
| Hôpital Edouard Herriot | Lyon | France | |
| Hôpital Femme Mère Enfant | Lyon | France | |
| Hôpital de la Timone | Marseille | France | |
| Hôpital Saint-Eloi | Montpellier | France | |
| Hôpital Brabois | Nancy | France | |
| Hôpital Hôtel Dieu | Nantes | France | |
| Hôpital Européen Georges Pompidou | Paris | France | |
| Hôpital Nord | Saint-Etienne | France | |
| Hôpital Rangueil | Toulouse | France | |
| Hôpital Trousseau | Tours | France |
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Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05976841 on ClinicalTrials.gov ↗ ← All trials in France