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

NCT04846556 | Completed

• 1 other identifier: IRBN352021/CHUSTE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Venous Thromboembolism; Cancer

Keywords

Cancer; thrombosis; epidemiology; cancer-associated venous thromboembolism (CAT); venous thromboembolic event

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Drugs used for their VTE

  Up to 6 months after venous thromboembolic event

• Confirmed recurrent Venous Thromboembolic Event (VTE)

  Up to 6 months after venous thromboembolic event

• Bleeding event

  Up to 6 months after venous thromboembolic event

• Death

  Up to 6 months after venous thromboembolic event

Study Arms (1)

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

Interventions

data collection 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).

venous thromboembolic event related to cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• pregnant women or breast feeding

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

CHU d'Amiens

Amiens, 80000, France

Location

Hôpital Louis Mourier

Colombes, 92000, France

Location

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Venous Thromboembolism; Neoplasms; Thrombosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laurent Bertoletti, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: April 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)