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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04846556
• Other study ID #: IRBN352021/CHUSTE
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Thrombosis
• Venous Thromboembolism

Intervention

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).

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	Hôpital Louis Mourier	Colombes
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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