Clinical trial NCT04846556: Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO
Official title: Cancer Associated Thrombosis: What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO (a Retrospective Multicenter Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Cancer
Keywords: Cancer
thrombosis
epidemiology
cancer-associated venous thromboembolism (CAT)
venous thromboembolic event
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for a venous thromboembolic event related to their cancer will be included between 2017 and 2019 at Saint-Etienne University Hospital, Louis-Mourier Hospital (AP-HP) and Amiens University Hospital.

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study
timeFrame: Up to 6 months after venous thromboembolic event
Secondary outcomes:
measure: Drugs used for their VTE
timeFrame: Up to 6 months after venous thromboembolic event
measure: Confirmed recurrent Venous Thromboembolic Event (VTE)
timeFrame: Up to 6 months after venous thromboembolic event
measure: Bleeding event
timeFrame: Up to 6 months after venous thromboembolic event
measure: Death
timeFrame: Up to 6 months after venous thromboembolic event
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Laurent Bertoletti, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: