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

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.

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Key information

Conditions

Cancer Cardiovascular Diseases Deep Venous Thrombosis Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Louis Mourier, Colombes, Île-de-France Region, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

venous thromboembolism

Time frame: 6 months after enrollment

Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism

Secondary outcomes

all-cause mortality

Time frame: 6 months after enrollment

Sponsors and collaborators

Lead sponsor

Harry R. Buller

Other

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam UMC, location VUmc
Hôpital Louis Mourier
Instituto Nacional de Cancerologia de Mexico
Slotervaart Hospital
University Medical Center Groningen
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Registry information

Official study title

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

Acronym: MICA

Important dates

Study start: 2008
Primary completion: 2016
Study completion: 2017
First posted: Mar 26, 2014
Registry last updated: Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed