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Clinical Trials/NCT06258694
NCT06258694
Completed
Not Applicable

Venous Thrombo-Embolism Imaging Database

University Hospital, Brest1 site in 1 country2,208 target enrollmentJanuary 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Thromboembolism
Sponsor
University Hospital, Brest
Enrollment
2208
Locations
1
Primary Endpoint
VTE recurrence
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

Using a large imaging data in VTE (including ultrasound, CT-scan and Ventilation/Perfusion lung scan), the investigators will search for association between imaging data and VTE phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients. These imaging biomarkers will be validated using an internal cross validation technique.

Registry
clinicaltrials.gov
Start Date
January 14, 2021
End Date
February 15, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years or older.
  • Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism).
  • Inclusion in the EDITH (Etude des Déterminants et Interaction de la THrombose veineuse) between November 2009 and November
  • No opposition to be included in the present study.

Exclusion Criteria

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

Outcomes

Primary Outcomes

VTE recurrence

Time Frame: At enrollment (retrospective follow up to 2 years)

VTE recurrence, including Pulmonary Embolism and Deep Vein Trombosis

Distinguishing provoked from unprovoked VTE

Time Frame: At enrollment

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)

Secondary Outcomes

  • Individual phenotyping(At enrollment)

Study Sites (1)

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