NCT04711746

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
544

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4.9 years

First QC Date

January 13, 2021

Last Update Submit

May 23, 2025

Conditions

Pulmonary EmbolismHematopoiesis

Keywords

Pulmonary Embolismhematopoiesisgenetic sequencingendothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Previous proximal unprovoked pulmonary embolism

EXPERIMENTAL
Biological: blood sample

Previous proximal provoked pulmonary embolism

ACTIVE COMPARATOR
Biological: blood sample

Interventions

blood sampleBIOLOGICAL

Blood sample withdrawal in order to perform DNA sequencing

Previous proximal provoked pulmonary embolismPrevious proximal unprovoked pulmonary embolism

Eligibility Criteria

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

You may qualify if:

  • For cases : Previous proximal unprovoked pulmonary embolism, negative thrombophilia screening.
  • For control : Previous proximal provoked pulmonary embolism, negative thrombophilia screening.

You may not qualify if:

  • Age superior to 65 years old,
  • Active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Simon SOUDET, MD

CONTACT

03 22 88 72 89soudet.simon@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

February 1, 2021

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)