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
  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


Estimated Enrollment: 1000
Study Start Date: July 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (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
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

Contacts
Contact: Nick van Es, MD +31205666023 n.vanes@amc.nl

Locations
France
Hopital Louis Mourier Recruiting
Colombes, Ile-de-France, France, 92700
Contact: Isabelle Mahé, MD       isabelle.mahe@lmr.aphp.fr   
Principal Investigator: Isabelle Mahé, MD         
Italy
Hospital D'Annunziata Recruiting
Chieti, Italy, 66013
Contact: Marcello di Nisio, MD PhD       mdinisio@unich.it   
Principal Investigator: Marcello di Nisio, MD PhD         
Mexico
Instituto Nacional de Cancerología Recruiting
Mexico City, Mexico
Contact: Gabriela Cesarman, MD       gcesarman@gmail.com   
Principal Investigator: Gabriela Cesarman, MD         
Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Harry Büller, MD PhD       h.r.buller@amc.nl   
Principal Investigator: Harrr Büller, MD PhD         
Sub-Investigator: Nick van Es, MD         
Sub-Investigator: Suzanne Bleker, MD         
VU medical center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HZ
Contact: Prabath Nanayakkara, MD PhD       P.Nanayakkara@vumc.nl   
Principal Investigator: Prabath Nanayakkara, MD PhD         
Slotervaart hospital Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 EC
Contact: Hans-Martin Otten, MD PhD       Hans-Martin.Otten@slz.nl   
Principal Investigator: Hans-Martin Otten, MD PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: PW Kamphuisen, MD PhD       p.w.kamphuisen@umcg.nl   
Principal Investigator: PW Kamphuisen, MD PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Harry 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: March 22, 2014
Health Authority: The Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on September 14, 2014