Screening for Occult Malignancy in Idiopathic Venous Thromboembolism
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diagnostic screening for occult malignancy
Sponsored by
About this trial
This is an interventional diagnostic trial for Venous Thromboembolism
Eligibility 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
Sites / Locations
- Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00361647
Brief Title
Screening for Occult Malignancy in Idiopathic Venous Thromboembolism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Padova
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Diagnostic screening for occult malignancy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Prandoni, MD, PhD
Organizational Affiliation
Department of Medical and Surgical Sciences, University of Padua, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
City
Padua
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
34597414
Citation
Robertson L, Broderick C, Yeoh SE, Stansby G. Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE. Cochrane Database Syst Rev. 2021 Oct 1;10(10):CD010837. doi: 10.1002/14651858.CD010837.pub5.
Results Reference
derived
PubMed Identifier
27764880
Citation
Prandoni P, Bernardi E, Valle FD, Visona A, Tropeano PF, Bova C, Bucherini E, Islam MS, Piccioli A. Extensive Computed Tomography versus Limited Screening for Detection of Occult Cancer in Unprovoked Venous Thromboembolism: A Multicenter, Controlled, Randomized Clinical Trial. Semin Thromb Hemost. 2016 Nov;42(8):884-890. doi: 10.1055/s-0036-1592335. Epub 2016 Oct 20.
Results Reference
derived
Learn more about this trial
Screening for Occult Malignancy in Idiopathic Venous Thromboembolism
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