Impact of Von Willebrand Factor and Its Multimers on Angiogenesis (WILLANGIO)

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.

Study Overview

• Status: Recruiting
• Conditions: Von Willebrand Diseases
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Recruiting
    • CHU de Nantes
    • Contact: Marc Fouassier; Phone Number: 0240084049; Email: marc.fouassier@chu-nantes.fr)
    • Principal Investigator: Marc Fouassier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The studied population will be composed of:

• 70 patients with von Willebrand disease: 10 type 1 patients, 10 type 2A (IIA) patients, 10 type 2A (IIE) patients, 10 type 2B patients, 10 type 2M patients, 10 type 2M patients (2A-like) and 10 type 3 patients.
• 20 healthy volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with von Willebrand disease	Other: no intervention; no intervention
case control	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): August 7, 2024
• Study Completion (Estimated): August 7, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Blood Platelet Disorders; Von Willebrand Diseases
• Other Study ID Numbers: RC20_0531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No