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

Cancer Clinical Trial

— MICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095925
• Other study ID #: MICA
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: January 16, 2017
• Start date: July 2008
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
France	Hopital Louis Mourier	Colombes	Ile-de-France
Italy	Hospital D'Annunziata	Chieti
Mexico	Instituto Nacional de Cancerología	Mexico City
Netherlands	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

Sponsors (8)

Lead Sponsor	Collaborator
Harry R. Buller	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Hôpital Louis Mourier, Instituto Nacional de Cancerologia de Mexico, Slotervaart Hospital, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, University Medical Center Groningen, VU University Medical Center

Countries where clinical trial is conducted

France,  Italy,  Mexico,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	venous thromboembolism	Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism	6 months after enrollment
Secondary	all-cause mortality		6 months after enrollment