Prevention and Prophylaxis of Cancer Associated Thrombosis in High Risk Oncology Patients

Pulmonary Embolism Clinical Trial

Official title:

Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03909399
• Other study ID #: ACT4CAT
• Status: Recruiting
• Start date: January 25, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2020
• Source: Hellenic Society of Medical Oncology
• Contact: Nikolaos Tsoukalas, MD
• Phone: +302107288598
• Email: tsoukn[@]yahoo.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.

Description:

Venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), is a highly prevalent complication of malignancy. The development of VTE in cancer patients is associated with several adverse consequences including worsened short- and long-term prognosis and survival, mortality, morbidity, chemotherapy postponement, potential hospitalization, need for long-term anticoagulation with attendant bleeding complications and high rates of recurrent VTE . In addition, VTE leads to significant consumption of health care resources; in one study of cancer patients, the adjusted mean incremental all-cause health care costs of VTE were $30,538 per patient. Therefore, the optimal prevention and treatment of VTE are crucial components of patient care in this population. Currently, Low-Molecular-Weight Heparin (LMWH), is the gold standard for the CAT management for the last 15 years Moreover, in a variety of high-risk thrombosis clinical settings, LMWHs agents are safe and effective in preventing VTE. Multiple randomized trials of thromboprophylaxis have been conducted focusing on ambulatory cancer patients receiving chemotherapy. ESMO and ASCO current guidelines suggest considering thromboprophylaxis in high-risk ambulatory cancer patients with LMWHs. ECOG index, metastatic malignancy, chemotherapy and history of thrombosis were significantly associated with the decision to use thromboprophylaxis in most situations.

Additionally, in 2016 Hellenic Society of Medical Oncology (HeSMO) has conducted the GMaT study to assess the awareness of Thrombosis and highlight the current clinical practice in Greece. The study has precluded adoption of outpatient prophylaxis in largely unselected patients with cancer without significant adverse events. Based on GMaT findings, the investigators will proceed in an observational study focusing on thromboprophylaxis in cancer patients with high thrombotic cancer types. In particular, the title of this new study will be "Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria

• Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic, genitourinary or CNS).

• Patients who have already started on thromboprophylaxis treatment according to the current clinical practice guidelines and the clinical judgment of treating physician after discussion with patient, within three months before the study enrollment.

• Age = 18 years

• ECOG 0-2

• Life expectancy >6 months

• Signed informed consent

Exclusion criteria

• Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic, genitourinary or CNS).

• Patients who have not already started on thromboprophylaxis treatment according to the current clinical practice guidelines or who have already started on thromboprophylaxis but more than three months before the study enrollment.

• Age < 18 years

• ECOG >2

• Life expectancy <6 months

• Not signed informed consent

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Iliac; Thrombosis
• Pulmonary Embolism
• Thrombosis
• Vena Cava Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Greece	Hellenic Society of Medical Oncology	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Society of Medical Oncology

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording all objectively confirmed VTE events for 500 patients during the treatment period	Recording the rate of symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and vena cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and P, will also be recorded the agent, the dose and the duration of the antithrombotic therapy	1 YEAR