Screening for Occult Malignancy in Idiopathic Venous Thromboembolism
June 10, 2008 updated by: University of Padova
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Padua, Italy, 35128
- Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paolo Prandoni, MD, PhD, Department of Medical and Surgical Sciences, University of Padua, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
August 7, 2006
First Submitted That Met QC Criteria
August 7, 2006
First Posted (Estimate)
August 8, 2006
Study Record Updates
Last Update Posted (Estimate)
June 13, 2008
Last Update Submitted That Met QC Criteria
June 10, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 719P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.