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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University Medical Center
University Medical Centre Groningen
Slotervaart Hospital
Hôpital Louis Mourier
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Instituto Nacional de Cancerologia de Mexico
Information provided by (Responsible Party):
Harry Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02095925
First received: March 21, 2014
Last updated: March 22, 2014
Last verified: March 2014

March 21, 2014
March 22, 2014
July 2008
June 2015   (final data collection date for primary outcome measure)
venous thromboembolism [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism
Same as current
Complete list of historical versions of study NCT02095925 on ClinicalTrials.gov Archive Site
all-cause mortality [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

citrated plasma

Non-Probability Sample

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

  • Cancer
  • Deep Venous Thrombosis
  • Pulmonary Embolism
Not Provided
cancer patients
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2015
June 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Nick van Es, MD +31205666023 n.vanes@amc.nl
France,   Italy,   Mexico,   Netherlands
 
NCT02095925
MICA
No
Harry Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Harry Buller
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • VU University Medical Center
  • University Medical Centre Groningen
  • Slotervaart Hospital
  • Hôpital Louis Mourier
  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara
  • Instituto Nacional de Cancerologia de Mexico
Not Provided
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP