Cohort Study to Identify Cancer Patients at High Risk of Venous Thromboembolism
Conditions
Cancer - Deep Venous Thrombosis - Pulmonary Embolism
Conditions: official terms
Pulmonary Embolism - Thrombosis - Venous Thromboembolism - Venous Thrombosis
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)
Locations
Hopital Louis Mourier
Colombes, Ile-de-France, France
Status: Recruiting
Contact: Isabelle Mahé, MD - isabelle.mahe@lmr.aphp.fr
Hospital D'Annunziata
Chieti, Italy
Status: Recruiting
Contact: Marcello di Nisio, MD PhD - mdinisio@unich.it
Instituto Nacional de Cancerología
Mexico City, Mexico
Status: Recruiting
Contact: Gabriela Cesarman, MD - gcesarman@gmail.com
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands
Status: Recruiting
Contact: Harry Büller, MD PhD - h.r.buller@amc.nl
Slotervaart hospital
Amsterdam, Noord-Holland, Netherlands
Status: Recruiting
Contact: Hans-Martin Otten, MD PhD - Hans-Martin.Otten@slz.nl
VU medical center
Amsterdam, Noord-Holland, Netherlands
Status: Recruiting
Contact: Prabath Nanayakkara, MD PhD - P.Nanayakkara@vumc.nl
University Medical Center Groningen
Groningen, Netherlands
Status: Recruiting
Contact: PW Kamphuisen, MD PhD - p.w.kamphuisen@umcg.nl
Start Date
July 2008
Completion Date
December 2015
Sponsors
Harry R. Buller
Source
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page