Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO

NCT ID: NCT04846556

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-06-30

Brief Summary

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Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.

Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.

However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.

Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.

The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.

Detailed Description

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The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).

Conditions

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Venous Thromboembolism Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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venous thromboembolic event related to cancer

Patients admitted for a venous thromboembolic event related to their cancer will be included A data collection will be realized. Patients admitted between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital.

data collection

Intervention Type OTHER

data collection : gender, weight, biological data (platelets, hemoglobin, creatinine, liver function tests), performance status, type of Venous Thromboembolic Event (VTE) and cancer, anticancer and anticoagulant therapy, adverse events (bleeding, recurrence of Venous Thromboembolic Event (VTE), death) up to 6 months after their Venous Thromboembolic Event (VTE).

Interventions

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data collection

data collection : gender, weight, biological data (platelets, hemoglobin, creatinine, liver function tests), performance status, type of Venous Thromboembolic Event (VTE) and cancer, anticancer and anticoagulant therapy, adverse events (bleeding, recurrence of Venous Thromboembolic Event (VTE), death) up to 6 months after their Venous Thromboembolic Event (VTE).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Consecutive patients with a newly diagnosed, objectively confirmed:

* symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)
* symptomatic or unsuspected Pulmonary Embolism (PE)

Consecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:

* Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.
* Cancer diagnosed within 2 years.

Exclusion Criteria

* pregnant women or breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Bertoletti, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU d'Amiens

Amiens, , France

Site Status

HĂ´pital Louis Mourier

Colombes, , France

Site Status

Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN352021/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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