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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04711746

Collaborator

(none)

544

Enrollment

Location

Arms

Anticipated Duration (Months)

23.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism Hematopoiesis	Biological: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

544 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Previous proximal unprovoked pulmonary embolism	Biological: blood sample Blood sample withdrawal in order to perform DNA sequencing
Active Comparator: Previous proximal provoked pulmonary embolism	Biological: blood sample Blood sample withdrawal in order to perform DNA sequencing

Arm

Intervention/Treatment

Experimental: Previous proximal unprovoked pulmonary embolism

Biological: blood sample

Blood sample withdrawal in order to perform DNA sequencing

Active Comparator: Previous proximal provoked pulmonary embolism

Biological: blood sample

Blood sample withdrawal in order to perform DNA sequencing

Outcome Measures

Primary Outcome Measures

Variation of CHIP markers between patients groups [up to 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT04711746

Other Study ID Numbers:

PI2020_843_0117

First Posted:

Jan 15, 2021

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Pulmonary Embolism

hematopoiesis

genetic sequencing

endothelial dysfunction

Additional relevant MeSH terms:

Pulmonary Embolism

Embolism

Study Results

No Results Posted as of Jul 21, 2021