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

NCT ID: NCT03909399

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2021-03-31

Brief Summary

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

Detailed 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".

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Society of Medical Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hellenic Society of Medical Oncology

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Nikolaos Tsoukalas, MD

Role: CONTACT

tsoukn@yahoo.gr

+302107288598

Facility Contacts

Kalliopi Sarikaki, SC

Role: primary

psarikaki@hesmo.gr

+302106457971

Other Identifiers

ACT4CAT

Identifier Type: -

Identifier Source: org_study_id