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Screening for Occult Malignancy in Idiopathic Venous Thromboembolism

This study has been completed.
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00361647
First received: August 7, 2006
Last updated: June 10, 2008
Last verified: June 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 7, 2006
Last Updated: June 10, 2008
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014