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

Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02095925

Acronym

MICA

Enrollment

900

Registered

2014-03-26

Start date

2008-07-31

Completion date

2017-01-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Deep Venous Thrombosis, Pulmonary Embolism

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
venous thromboembolism	6 months after enrollment	Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism

Secondary

Measure	Time frame
all-cause mortality	6 months after enrollment

Countries

France, Italy, Mexico, Netherlands

Outcome results