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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04810702
Other study ID # RC20_0531
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 7, 2024
Est. completion date August 7, 2024

Study information

Verified date March 2024
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to study the expression of numerous proteins involved in angiogenesis in 70 patients with von Willebrand disease in order to try to identify markers of interest. Secondly, the investigators plan to investigate whether there is a relationship between the proteins tested, the distribution of multimers and the clinical phenotype of the patients, in particular by looking for the presence of bleeding linked to the presence of angiodysplasias.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date August 7, 2024
Est. primary completion date August 7, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: For patients: - Patient with von Willebrand disease proven by genetic analysis of the VWF gene. - Lack of treatment that could interfere with angiogenesis. - Patient informed by an information note sent to his home, with the possibility of objecting to the use of his blood samples in the context of research. For the control: - Patient with a normal coagulation report - Absence of abnormal hemorrhagic symptoms - Lack of notion of angiodysplasia. - Lack of treatment that could interfere with angiogenesis. - Patient informed by an information note sent to his home, with the possibility of objecting to the use of his blood samples in the context of research. Exclusion Criteria: - Patient under guardianship or curatorship. - Pregnant and lactating women. - Blood transfusion or treatment with von Willebrand factor concentrates less than 7 days old. - Treatment which may interfere with angiogenesis.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
France CHU de Nantes Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To study the relationship between proteins involved in angiogenesis and the distribution of multimers in patients with von Willebrand disease in order to define markers of interest Compare the distribution of multimers assays between different groups of patients and the control group 1 year
Primary To study the relationship between proteins involved in angiogenesis and the distribution of multimers in patients with von Willebrand disease in order to define markers of interest Compare the distribution of protein assays between different groups of patients and the control group 1 year
Secondary To study the relationship between the distribution of multimers and the clinical phenotype of patients, and in particular the presence of angiodysplasias To study the correlation between the clinical phenotype and the assays of angiogenesis proteins 1 year
Secondary To study the relationship between the markers of interest and the clinical phenotype of patients, and in particular the presence of angiodysplasias To study the correlation between the clinical phenotype and the distribution of multimers 1 year
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