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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University Medical Center
University Medical Center 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 R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02095925
First received: March 21, 2014
Last updated: June 29, 2016
Last verified: June 2016

March 21, 2014
June 29, 2016
July 2008
June 2016   (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.
 
Active, not recruiting
1000
August 2016
June 2016   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Mexico,   Netherlands
 
NCT02095925
MICA
No
Not Provided
Not Provided
Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Harry R. Buller
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • VU University Medical Center
  • University Medical Center Groningen
  • Slotervaart Hospital
  • Hôpital Louis Mourier
  • Università degli Studi 'G. d'Annunzio' Chieti e Pescara
  • Instituto Nacional de Cancerologia de Mexico
Principal Investigator: Harry R Buller, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
June 2016

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