NCT02095925

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

7.9 years

First QC Date

March 21, 2014

Last Update Submit

January 16, 2017

Conditions

CancerDeep Venous ThrombosisPulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • venous thromboembolism

    Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism

    6 months after enrollment

Secondary Outcomes (1)

  • all-cause mortality

    6 months after enrollment

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Use of anticoagulants (heparin, vitamin K antagonists or direct oral anticoagulants)
  • Adjuvant chemotherapy (i.e. after surgery with curative intent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hopital Louis Mourier

Colombes, Île-de-France Region, 92700, France

Location

Hospital D'Annunziata

Chieti, 66013, Italy

Location

Instituto Nacional de Cancerología

Mexico City, Mexico

Location

Slotervaart hospital

Amsterdam, North Holland, 1066 EC, Netherlands

Location

VU medical center

Amsterdam, North Holland, 1081 HZ, Netherlands

Location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28550192DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

citrated plasma

MeSH Terms

Conditions

NeoplasmsVenous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Harry R Buller, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Harry R Büller, MD PhD

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

July 1, 2008

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

ME(1)FR(1)IT(1)NL(4)