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

NCT ID: NCT02095925

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Deep Venous Thrombosis Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Slotervaart Hospital

OTHER

Sponsor Role collaborator

Hôpital Louis Mourier

OTHER

Sponsor Role collaborator

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

OTHER

Sponsor Role collaborator

Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role collaborator

Harry R. Buller

OTHER

Sponsor Role lead

Responsible Party

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Harry R. Buller

Harry R Büller, MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Harry R Buller, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Hopital Louis Mourier

Colombes, Île-de-France Region, France

Site Status

Hospital D'Annunziata

Chieti, , Italy

Site Status

Instituto Nacional de Cancerología

Mexico City, , Mexico

Site Status

Slotervaart hospital

Amsterdam, North Holland, Netherlands

Site Status

VU medical center

Amsterdam, North Holland, Netherlands

Site Status

Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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France Italy Mexico Netherlands

References

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van 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.

Reference Type DERIVED
PMID: 28550192 (View on PubMed)

Other Identifiers

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MICA

Identifier Type: -

Identifier Source: org_study_id

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