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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Venous Thromboembolism
• Intervention / Treatment: Other: data collection

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).

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • CHU d'Amiens
  • Colombes, France, 92000
    • Hôpital Louis Mourier
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of cancer patients with a venous thromboembolic event (VTE) ineligible for CARAVAGGIO study	Patient having at least one of the following exclusion criteria (from CARAVAGGIO study) : ECOG (Eastern Cooperative Oncology Group ) Performance Status III or IV;; life expectancy of less than 6 months;; thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;; indication for anticoagulant treatment for a disease other than the index VTE episode;; thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;; recent brain, spinal or ophthalmic surgery; hemoglobin level lower than 8 g/dL or platelet count <75x10^9/L or history of heparin induced thrombocytopenia;; creatinine clearance < 30 ml /min; acute hepatitis, chronic active hepatitis, liver cirrhosis;; uncontrolled hypertension;; concomitant use of strong inhibitors or inducers of cytochrome;; bacterial endocarditis;	Up to 6 months after venous thromboembolic event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drugs used for their VTE	Collected in medical history.	Up to 6 months after venous thromboembolic event
Confirmed recurrent Venous Thromboembolic Event (VTE)	Collected in medical history.; Pulmonary embolism; deep venous thrombosis	Up to 6 months after venous thromboembolic event
Bleeding event	Collected in medical history.	Up to 6 months after venous thromboembolic event
Death	Collected in medical history.	Up to 6 months after venous thromboembolic event

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Laurent BERTOLETTI, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; epidemiology; thrombosis; cancer-associated venous thromboembolism (CAT); venous thromboembolic event
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: IRBN352021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No