Clinical trial NCT02095925: Cohort Study to Identify Cancer Patients at High Risk of Venous Thromboembolism
Official title: Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Deep Venous Thrombosis
Pulmonary Embolism
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Amsterdam UMC, location VUmc
name: University Medical Center Groningen
name: Slotervaart Hospital
name: Hôpital Louis Mourier
name: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
name: Instituto Nacional de Cancerologia de Mexico
First posted: 2014-03-26
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: venous thromboembolism
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: all-cause mortality
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier
state: Ile-de-France
city: Chieti
country: Italy
facility: Hospital D'Annunziata
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerología
city: Amsterdam
country: Netherlands
facility: Slotervaart hospital
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: VU medical center
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Harry R Buller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Es N, Di Nisio M, Cesarman G, Kleinjan A, Otten HM, Mahe I, Wilts IT, Twint DC, Porreca E, Arrieta O, Stepanian A, Smit K, De Tursi M, Bleker SM, Bossuyt PM, Nieuwland R, Kamphuisen PW, Buller HR. Comparison of risk prediction scores for venous thromboembolism in cancer patients: a prospective cohort study. Haematologica. 2017 Sep;102(9):1494-1501. doi: 10.3324/haematol.2017.169060. Epub 2017 May 26.