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
  Purpose
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.

Condition
Cancer
Deep Venous Thrombosis
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • venous thromboembolism [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
    Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism


Secondary Outcome Measures:
  • all-cause mortality [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
citrated plasma

Enrollment: 1000
Study Start Date: July 2008
Estimated Study Completion Date: August 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02095925

Locations
France
Hopital Louis Mourier
Colombes, Ile-de-France, France, 92700
Italy
Hospital D'Annunziata
Chieti, Italy, 66013
Mexico
Instituto Nacional de Cancerología
Mexico City, Mexico
Netherlands
Slotervaart hospital
Amsterdam, Noord-Holland, Netherlands, 1066 EC
VU medical center
Amsterdam, Noord-Holland, Netherlands, 1081 HZ
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
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
Investigators
Principal Investigator: Harry R Buller, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: Harry R. Buller, Harry R Büller, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02095925     History of Changes
Other Study ID Numbers: MICA 
Study First Received: March 21, 2014
Last Updated: June 29, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Thrombosis
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2016