Mortality Due to Malignancy in Patients With Idiopathic Venous Thromboembolism

NCT01088334 | Terminated DMC

• 1 other identifier: Trousseau studie
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 10

Brief 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. 1.Proven first symptomatic deep venous thromboembolic event;
2. 2.Without: known risk factor for venous thromboembolism.
3. 3.Proven deep venous thromboembolic event in the medical history, age under 40 years;
4. 4.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).

Conditions

Venous Thromboembolism; Malignancy

Keywords

Idiopathic venous thromboembolism; Malignancy; screening

Outcome Measures

Primary Outcomes (1)

• Mortality

  The responsible physician inform the investigators when a patient has died. The national registrar was checked at the end of the study for all patients

  at 3, 6, 12, 24, 36 months after inclusion and at the end of study

Secondary Outcomes (5)

• Residual objectified malignancy

  at 3, 6, 12, 24, 36 months after inclusion

• Recurrent objectified malignancy

  at 3, 6, 12, 24, 36 after inclusion.

• Malignancy detected by extensive screening, without alarm signs in routine examinations

  at 3 months after inclusion

• Costs of screening, of additional tests after screening

  at end of study.

• Medical complications of screening tests

  at 3 + 6 months and end of study

Study Arms (2)

IVTE, follow-up

no malignancy at basal screening, no extensive screening

IVTE, screening

No malignancy at basal screening, screening by means of CT-Chest/abdomen and mammography in women

Other: screening

Interventions

screening OTHER

CT-Chest/abdomen and mammography in women

IVTE, screening

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with IVTE diagnosed in academical centres and teaching hospitals in the Netherlands

You may qualify if:

• Proven first symptomatic deep venous thromboembolic event;
• No known malignancy
• Without: trauma of the legs, surgery within the last 2 months, immobilization within the last 2 months, thrombocytosis (\> 1000 x 109), clinical severe dehydration, deficiency of anti-thrombin III, protein C/S, Factor V Leiden mutation , Prothrombine mutation or circulating lupus anticoagulants, pregnancy or post-partum period
• No indication for malignancy at routine investigations(medical history, physical examination, routine blood tests and chest X-ray)

You may not qualify if:

• Proven deep venous thromboembolic event in the medical history
• age under 40 years;

Sponsors & Collaborators

• Slotervaart Hospital: lead

Study Sites (10)

Meander Medisch Centrum

Amersfoort, 3818 ES, Netherlands

Location

Slotervaarthospital

Amsterdam, 1066 EC, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1090 HM, Netherlands

Location

Academic Medical Center

Amsterdam, 1101 AZ, Netherlands

Location

Maxima Medisch Centrum

Eindhoven, 5631 BM, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 GZ, Netherlands

Location

Westfries Gasthuis

Hoorn, 1624 NP, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229 HX, Netherlands

Location

Diakonessenhuis Utrecht

Utrecht, 3582 KE, Netherlands

Location

Diakonessenhuis Zeist

Zeist, 3707 HL, Netherlands

Location

Related Publications (38)

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MeSH Terms

Conditions

Venous Thromboembolism; Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Hans-Martin MB Otten, MD PhD

  Slotervaart hospital and Academic Medical Center

  PRINCIPAL INVESTIGATOR

• Harry R Büller, Md PhD

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

  STUDY DIRECTOR

• Martin H Prins, MD PhD

  Maastricht Universitair Medisch Centrum

  STUDY CHAIR

• Frederiek F v. Doormaal, MD PhD

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

  STUDY CHAIR

• Wim Terpstra, MD PhD

  Onze Lieve Vrouwe Gasthuis

  STUDY CHAIR

• René vd Griend, MD PhD

  Diakonessenhuis, Utrecht

  STUDY CHAIR

• Marten Nijziel, MD PhD

  Maxima Medical Center

  STUDY CHAIR

• Marcel A vd Ree, MD PhD

  Diakonessenhuis Zeist

  STUDY CHAIR

• Jacob C Dutilh, MD

  Meander Medisch Centrum

  STUDY CHAIR

• A t. Cate-Hoek, MD PhD

  Maastricht Universitair Medisch Centrum

  STUDY CHAIR

• Simone M. vd Heiligenberg, MD

  Dijklander Ziekenhuis

  STUDY CHAIR

• Jan vd Meer, MD PhD

  University Medical Center Groningen

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 17, 2010
• Study Start: December 1, 2002
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 29, 2010

Record last verified: 2010-03

Locations

NL (10)