NCT06258694

Brief Summary

The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 14, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
3 years until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

January 29, 2021

Last Update Submit

February 12, 2024

Conditions

Venous ThromboembolismDeep Vein ThrombosisPulmonary Embolism

Keywords

Venous thromboembolismImage processingRadiomics

Outcome Measures

Primary Outcomes (2)

  • VTE recurrence

    VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis

    At enrollment (retrospective follow up to 2 years)

  • Distinguishing provoked from unprovoked VTE

    Provoked VTE is defined by the presence within the three past months, of a major risk factor (i.e. Surgery, Immobilization \> 3 days, Hormonal Treatment, Pregnancy, Cancer)

    At enrollment

Secondary Outcomes (1)

  • Individual phenotyping

    At enrollment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every patients included in the EDITH cohort between November 2009 and Novembre 2019, with a confirmed diagnosis of VTE.

You may qualify if:

  • years or older.
  • Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism).
  • No opposition to be included in the present study.

You may not qualify if:

  • Patients under 18 years old.
  • Patients under judicial protection.
  • Patient physically or cognitively unable to give consent.
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brest University Hospital

Brest, Finistere, 29200, France

Location

MeSH Terms

Conditions

Venous ThromboembolismVenous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisLung DiseasesRespiratory Tract DiseasesEmbolism

Study Design

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

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 14, 2024

Study Start

January 14, 2021

Primary Completion

February 14, 2021

Study Completion

February 15, 2021

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

FR(1)