NCT04810702

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
2.9 years until next milestone

Study Start

First participant enrolled

February 7, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 16, 2021

Last Update Submit

March 20, 2024

Conditions

Von Willebrand Diseases

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • To study the relationship between the distribution of multimers and the clinical phenotype of patients, and in particular the presence of angiodysplasias

    1 year

  • To study the relationship between the markers of interest and the clinical phenotype of patients, and in particular the presence of angiodysplasias

    1 year

Study Arms (2)

patients with von Willebrand disease

Other: no intervention

case control

Other: no intervention

Interventions

no interventionOTHER

no intervention

case controlpatients with von Willebrand disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen plasma fractions

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 23, 2021

Study Start

February 7, 2024

Primary Completion

August 7, 2024

Study Completion

August 7, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations

FR(1)