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Screening for Occult Malignancy in Idiopathic Venous Thromboembolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361647
First Posted: August 8, 2006
Last Update Posted: June 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Padova
  Purpose
Prospective controlled randomized study. Aim of this study is to assess the feasibility and sensitivity of CT scanning of the thorax, abdomen and pelvis for the detection of occult cancer in patients with idiopathic venous thromboembolism. Patients presenting with acute idiopathic venous thromboembolism, free from already known cancer and in whom a routine battery screening has excluded the presence of cancer, are randomized to receive either a CT scanning of the thorax, abdomen and pelvis (completed by mammography if not already performed in the past year, and by gastroscopy and/or colonoscopy in patients with positive hemoccult) or a diagnostic programme freely decided by attending physicians. Patients of either group in whom the search for cancer is negative are followed-up for two years to register the development of clinically symptomatic malignant disease. The rate of cancer detection and that of cancer development are compared between the two study groups.

Condition Intervention
Venous Thromboembolism Procedure: Diagnostic screening for occult malignancy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Further study details as provided by University of Padova:

Study Start Date: January 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • idiopathic venous thromboembolism

Exclusion Criteria:

  • cancer already known or shown by routine battery tests
  • previous venous thromboembolism
  • geographic inaccessibility for long-term follow-up
  • allergy to contrast medium
  • refusal of informed consensus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361647


Locations
Italy
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Padua, Italy, 35128
Sponsors and Collaborators
University of Padova
Investigators
Principal Investigator: Paolo Prandoni, MD, PhD Department of Medical and Surgical Sciences, University of Padua, Italy
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paolo Prandoni, Department of Medical and Surgical Sciences, University of Padua
ClinicalTrials.gov Identifier: NCT00361647     History of Changes
Other Study ID Numbers: 719P
First Submitted: August 7, 2006
First Posted: August 8, 2006
Last Update Posted: June 13, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases