Mortality Due to Malignancy in Patients With Idiopathic Venous Thromboembolism

Summary

Background

Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear if extensive screening for malignant disease leads to survival benefit in patients with an IVTE.

The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy and screening by means of a computer tomography (CT) of the chest and abdomen plus a mammography in women had the potential to be most cost-effective. The SOMIT study could not show a survival benefit due to the design of the study.

Primary objective: cancer related mortality

Methods:

The Trousseau study has been designed as a multicenter, prospective concurrently controlled cohort study.

Inclusion criteria:

1. Proven first symptomatic deep venous thromboembolic event;
2. Without: known risk factor for venous thromboembolism.

Exclusion criteria:

1. Proven deep venous thromboembolic event in the medical history, age under 40 years;
2. Patients without signs of malignancy after routine investigations (medical history, physical examination, laboratory investigations and chest X-ray) were included. Depending on the standard care in the hospital of interest, one group of patients has been screened by means of CT-chest and abdomen plus mammography, the other group had no additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6, 12, 24 and 36 months after the thromboembolic event).

Data like mortality rate, morbidity due to screening procedures, additional investigations, number of cancer patients detected by the extensive screening, number of cancer patients three years after the IVTE, number and kind of investigations performed and information about cancer treatment and hospitalization was collected. If this information indicate a survival benefit these data enable us to perform a cost-effectiveness analysis.

Endpoint: Mortality.

Statistics:

Based on the prevalence of occult malignancy in VTE patients, the nature and stage of malignancies, the expected mortality, the anticipated detection of cancers and the early treatment related decrease in mortality we needed, in order to detect a true difference of this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients for each group. Therefore, a total of 1500 patients is required for this study.

Conditions

• Venous Thromboembolism
• Malignancy

Interventions

OTHER

screening

CT-Chest/abdomen and mammography in women

Sponsors & Collaborators

• Slotervaart Hospital

  lead OTHER

Principal Investigators

• Hans-Martin MB Otten, MD PhD · Slotervaart hospital and Academic Medical Center

• Harry R Büller, Md PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Martin H Prins, MD PhD · Maastricht Universitair Medisch Centrum

• Frederiek F v. Doormaal, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Wim Terpstra, MD PhD · Onze Lieve Vrouwe Gasthuis

• René vd Griend, MD PhD · Diakonessenhuis, Utrecht

• Marten Nijziel, MD PhD · Maxima Medical Center

• Marcel A vd Ree, MD PhD · Diakonessenhuis Zeist

• Jacob C Dutilh, MD · Meander Medisch Centrum

• A t. Cate-Hoek, MD PhD · Maastricht Universitair Medisch Centrum

• Simone M. vd Heiligenberg, MD · Dijklander Ziekenhuis

• Jan vd Meer, MD PhD · University Medical Center Groningen

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-12-31

Primary Completion

2008-05-31

Completion

2008-12-31

Countries

• Netherlands

Study Locations