Cohort Study to Identify Cancer Patients at High Risk of Venous Thromboembolism

Completed

• Conditions: Pulmonary Embolism; Cancer; Deep Venous Thrombosis

• Registration Number: NCT02095925
• Lead Sponsor: Harry R. Buller

Brief Summary

Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism, collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer patients have been previously developed by the groups of Khorana and Vienna CATS. However, routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently not recommended. In the investigators prospective, observational cohort study, the investigators aim to identify cancer patients at high risk for VTE based on clinical characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing microparticles.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-22
• Study First Posted: 2014-03-26
• Primary Completion: 2016-06
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Stage III or IV esophageal carcinoma, gastric carcinoma, intestinal carcinoma, pancreatic carcinoma, ovarian cancer, breast carcinoma, prostate cancer, urothelial cell carcinoma or lung carcinoma (small cell or non-small cell) who have started chemotherapy no more than 3 months ago
• Chemotherapy started no more than 3 months ago or within 7 days after enrollment
• Aged 18 years or older
• Written informed consent

Exclusion Criteria

• Use of anticoagulants (heparin, vitamin K antagonists or direct oral anticoagulants)
• Adjuvant chemotherapy (i.e. after surgery with curative intent)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
venous thromboembolism	6 months after enrollment	Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	6 months after enrollment

Trial Locations

Locations (7)

Hospital D'Annunziata; 🇮🇹 Chieti, Italy

Hopital Louis Mourier; 🇫🇷 Colombes, Ile-de-France, France

Instituto Nacional de Cancerología; 🇲🇽 Mexico City, Mexico

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Slotervaart hospital; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

VU medical center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands