CancerMICANCT02095925
Cohort Study to Identify Cancer Patients at High Risk of Venous Thromboembolism
An observational study of Cancer and Deep Venous Thrombosis, run by Harry R. Buller at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Deep Venous Thrombosis, Pulmonary Embolism
- Type of treatment
- Injection or infusion
- How many people
- 900 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jul 2008to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Use of anticoagulants (heparin, vitamin K antagonists or direct oral anticoagulants)
- Adjuvant chemotherapy (i.e. after surgery with curative intent)
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Netherlands4 sites
Slotervaart hospital
Amsterdam, North Holland, 1066 EC
VU medical center
Amsterdam, North Holland, 1081 HZ
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
University Medical Center Groningen
Groningen, Provincie Groningen
About this study
Official title: 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.
- Conditions
- Cancer, Deep Venous Thrombosis, Pulmonary Embolism
- Medical subject headings
- Neoplasms, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
venous thromboembolism
Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism
Measured: 6 months after enrollment
Secondary outcomes (1)
all-cause mortality
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJul 2008
- Primary completionJun 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harry R. Buller
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, University Medical Center Groningen, Slotervaart Hospital, Hôpital Louis Mourier, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, Instituto Nacional de Cancerologia de Mexico
- Responsible party
- Sponsor-investigator, Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Harry R Buller, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095925
- Sponsor's protocol ID
- MICA
- Acronym
- MICA
- Status last verified
- Jan 2017
- First submitted
- 21 Mar 2014
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Buijs JT, van Es N, Englisch C, Anijs RJS, Bosch FTM, van Vlijmen BJM, Mulder FI, Pabinger I, Ay C, Versteeg HH, Mohammed Y. Absolute quantitative proteomics identifies patterns of plasma proteins associated with venous thromboembolism in patients with colorectal cancer. Thromb Res. 2026 Mar;259:109612. doi: 10.1016/j.thromres.2026.109612. Epub 2026 Feb 6.
PubMed 41690262van Es N, Di Nisio M, Cesarman G, Kleinjan A, Otten HM, Mahe I, Wilts IT, Twint DC, Porreca E, Arrieta O, Stepanian A, Smit K, De Tursi M, Bleker SM, Bossuyt PM, Nieuwland R, Kamphuisen PW, Buller HR. Comparison of risk prediction scores for venous thromboembolism in cancer patients: a prospective cohort study. Haematologica. 2017 Sep;102(9):1494-1501. doi: 10.3324/haematol.2017.169060. Epub 2017 May 26.
PubMed 28550192
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis
- ClinicalTrials.gov ID
- NCT02095925
- Acronym / sponsor ID
- MICA / MICA
- Conditions
- Cancer, Deep Venous Thrombosis, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Harry R. BullerUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, University Medical Center Groningen, Slotervaart Hospital, Hôpital Louis Mourier, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, Instituto Nacional de Cancerologia de Mexico
- Study start
- Jul 2008
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Use of anticoagulants (heparin, vitamin K antagonists or direct oral anticoagulants)
- Adjuvant chemotherapy (i.e. after surgery with curative intent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
venous thromboembolism
Time frame: 6 months after enrollment
Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism
1 secondary outcome
all-cause mortality
Time frame: 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Derived from this study: PubMed 41690262Buijs JT, van Es N, Englisch C, Anijs RJS, Bosch FTM, van Vlijmen BJM, Mulder FI, Pabinger I, Ay C, Versteeg HH, Mohammed Y. Absolute quantitative proteomics identifies patterns of plasma proteins associated with venous thromboembolism in patients with colorectal cancer. Thromb Res. 2026 Mar;259:109612. doi: 10.1016/j.thromres.2026.109612. Epub 2026 Feb 6.
- Derived from this study: PubMed 28550192van Es N, Di Nisio M, Cesarman G, Kleinjan A, Otten HM, Mahe I, Wilts IT, Twint DC, Porreca E, Arrieta O, Stepanian A, Smit K, De Tursi M, Bleker SM, Bossuyt PM, Nieuwland R, Kamphuisen PW, Buller HR. Comparison of risk prediction scores for venous thromboembolism in cancer patients: a prospective cohort study. Haematologica. 2017 Sep;102(9):1494-1501. doi: 10.3324/haematol.2017.169060. Epub 2017 May 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry R Buller, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Deep Venous Thrombosis, run by Harry R. Buller at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, France, Italy, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
venous thromboembolism (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.