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NCT04711746 Clinical Trial

Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

Pulmonary Embolism Clinical Trial

— HEMEP  

Official title:
Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04711746
Other study ID # PI2020_843_0117
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date January 2024

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Simon SOUDET, MD
Phone 03 22 88 72 89
Email soudet.simon@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The clonal hematopoiesis of indetermined prognosis (CHIP) has been described as risk factor for juvenile atherosclerosis. Moreover, some of CHIP genes are responsible of myeloproliferative disorders. Venous thrombosis are frequent in these disorders. The purpose of this project is to determine if CHIP is frequent in unprovoked pulmonary embolism and could be part of the pathophysiology.

Recruitment information / eligibility
Status Recruiting
Enrollment 544
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - For cases : Previous proximal unprovoked pulmonary embolism, negative thrombophilia screening. - For control : Previous proximal provoked pulmonary embolism, negative thrombophilia screening. Exclusion Criteria: - Age superior to 65 years old, - Active cancer

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• blood sample
Blood sample withdrawal in order to perform DNA sequencing

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variation of CHIP markers between patients groups Variation of CHIP markers (clonal hematopoiesis of indetermined prognosis ) between patients groups.
CHIP concept have been defined as a mutation of preleukemic genes at an allelic variation inferior to 2% associated with normal complete blood count.		 up to 2 years
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