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

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ClinicalTrials.gov Identifier: NCT04711746
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Variation of CHIP markers between patients groups [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711746


Contacts
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Contact: Simon SOUDET, MD 03 22 88 72 89 soudet.simon@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: SOUDET Simon, MD    03 22 88 72 89    soudet.simon@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04711746    
Other Study ID Numbers: PI2020_843_0117
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Pulmonary Embolism
hematopoiesis
genetic sequencing
endothelial dysfunction
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases