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Ehlers-Danlos Syndrome, Vascular TypeNCT05976841

SEDVasc (RaDiCo Cohort) (RaDiCo-SEDVasc)

An observational study of Ehlers-Danlos Syndrome, Vascular Type, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Ehlers-Danlos Syndrome, Vascular Type
How many people
340 participants
Where
17 sitesFrance
Study dates
5 Dec 2016to Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients diagnosed as vEDS on a positive genetic testing on the COL3A1 gene.

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • Centre Hospitalier Universitaire Angers

    Angers

  • Hôpital Saint-André

    Bordeaux

  • Hôpital de la Cavale Blanche

    Brest

  • Hôpital Côte de Nacre

    Caen

  • Hôpital Gabriel Montpied

    Clermont-Ferrand

  • Hôpital Michallon

    Grenoble

  • Hôpital Claude Huriez

    Lille

  • Hôpital Edouard Herriot

    Lyon

  • Hôpital Femme Mère Enfant

    Lyon

  • Hôpital de la Timone

    Marseille

  • Hôpital Saint-Eloi

    Montpellier

  • Hôpital Brabois

    Nancy

  • Hôpital Hôtel Dieu

    Nantes

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Nord

    Saint-Etienne

  • Hôpital Rangueil

    Toulouse

  • Hôpital Trousseau

    Tours

Other trials in France

About this study

Official title: National Cohort on the Vascular Ehlers-Danlos Syndrome (SEDv)

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).

Medical subject headings
Ehlers-Danlos Syndrome, Type IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Through study completion, an average of 3 years

  2. Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on functional criteria (spontaneous arterial, digestive, obstetrical and pulmonary events)

    Measured: Through study completion, an average of 3 years

  3. Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on surgical criteria (types and complications)

    Measured: Through study completion, an average of 3 years

  4. 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)

    Measured: Through study completion, an average of 3 years

  5. Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on evaluation of mortality (death, disability)

    Measured: Through study completion, an average of 3 years

  6. Description of the natural course of vascular Ehlers-Danlos syndrome (vEDS) based on the presence of complications at delivery or after C-section

    Measured: Through study completion, an average of 3 years

Secondary outcomes (9)

  1. Study of prospective genotype-phenotype relationships

    Mutations of the COL3A1 gene are stratified within 5 classes (Frank et al. Eur J Hum Genet 2015):

    1. Glycine substitutions,
    2. splice-site and in-frame insertions-deletions,
    3. variants leading to haplo-insufficiency,
    4. non-glycine missense variants within the triple helix,
    5. non-glycine missense variants or in-frame insertions-deletions, in the N- or C-terminal part of the protein

    An association study between the type of mutation in the COL3A1 gene (individually or combined in two groups: (a+b) versus (c+d+e)) and the clinical phenotype or co-factors of morbidity (medication, lifestyle, smoking, physical activity…) will be performed. This study will be based on explicative multivariate analysis (e.g.: PCA, Logistic regression, ect.) and relevant association will be quantified by the corresponding correlation coefficient.

    Measured: Through study completion, an average of 3 years

  2. Study of the intrafamilial phenotypes relationships

    This study will be based on an explicative multivariate analysis (eg: PCA, Logistic regression, ect.) and relevant associations will be quantified by the corresponding correlation coefficients. Distribution of clinical symptoms with a positive correlation with the family history, will be displayed and illustrated by appropriate graphic method (Bar chart, box plot, forest plot, etc.).

    Measured: Through study completion, an average of 3 years

  3. Evaluation of the global cost of vEDS cares

    The analysis of the global cost of vEDS cares will be detailed by type of expenditure. The average cost will be estimated with health-care payer's perspective, i.e. the French health insurance system.

    After estimating the average global cost of vEDS cares, including both standard pathway's cost and vEDS' cost, a Tornado diagram will analyse the impact of the change of one or more parameters used in the analysis process. This will allow us to identify which parameters have an impact on the result by introducing uncertainties on values used. These parameters will vary in a range obtained by literature review, expert opinion or arbitrarily by simulation on a normal distribution.

    All the results will be drafted in statistical medico-economic analysis report to be presented to all investigators at the end of the study.

    Measured: Through study completion, an average of 3 years

  4. Evaluation of the therapeutic management

    A descriptive analysis of the different types of medication (celiprolol alone or associated to another drug) and their association to disease progression and life style will be performed by evaluating the number of lesions and/or the increased severity of the lesions and/or the appearance of lesions at different anatomical site.

    Measured: Through study completion, an average of 3 years

  5. Assessment of the correlation between the diffusion of arterial lesions and the occurrence of cardiovascular complication

    Measured: Through study completion, an average of 3 years

  6. Assessment of the repercussions of vEDS on patients' quality of life evaluated through scores of quality of life questionnaire Short-Form Health Survey (SF-36)

    Measured: Through study completion, an average of 3 years

  7. Assessment of the repercussions of vEDS on patients' quality of life evaluated through scores of quality of life questionnaire Short-Form Health Survey (SF-10)

    Measured: Through study completion, an average of 3 years

  8. Assessment of the repercussions of vEDS on patients' quality of life evaluated through scores of quality of life questionnaire HADS

    Measured: Through study completion, an average of 3 years

  9. Assessment of the repercussions of vEDS on patients' quality of life evaluated through scores of quality of life questionnaire socio-professional life

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start5 Dec 2016
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

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
Cohort
Time perspective
Other
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05976841
Sponsor's protocol ID
C15-65
Status last verified
Feb 2026
First submitted
18 Jul 2023
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ehlers-Danlos Syndrome, Vascular Type, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 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 4 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

This study is still under way. Results are not available in the source record yet.

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?

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) (time frame: Through study completion, an average of 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05976841.

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 12 Feb 2026.

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