Overview

This trial is active, not recruiting.

Conditions cancer, deep venous thrombosis, pulmonary embolism
Sponsor Harry R. Buller
Collaborator Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date July 2008
End date June 2016
Trial size 1000 participants
Trial identifier NCT02095925, MICA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with 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

Primary Outcomes

Measure
venous thromboembolism
time frame: 6 months after enrollment

Secondary Outcomes

Measure
all-cause mortality
time frame: 6 months after enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis
Principal investigator Harry R Buller, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).