Screening for Occult Malignancy in Idiopathic Venous Thromboembolism

Venous Thromboembolism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361647
• Other study ID #: 719P
• Status: Completed
• Phase: N/A
• First received: August 7, 2006
• Last updated: June 10, 2008
• Start date: January 2006

Study information

• Verified date: June 2008
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2008
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Procedure:
• Diagnostic screening for occult malignancy

Locations

Country	Name	City	State
Italy	Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua	Padua

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy,