Screening for Occult Malignancy in Idiopathic Venous Thromboembolism
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 7, 2006
CompletedFirst Posted
Study publicly available on registry
August 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedJune 13, 2008
June 1, 2008
2.3 years
August 7, 2006
June 10, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- idiopathic venous thromboembolism
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua
Padua, Padua, 35128, Italy
Related Publications (2)
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.
PMID: 34597414DERIVEDPrandoni 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.
PMID: 27764880DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Prandoni, MD, PhD
Department of Medical and Surgical Sciences, University of Padua, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 7, 2006
First Posted
August 8, 2006
Study Start
January 1, 2006
Primary Completion
May 1, 2008
Last Updated
June 13, 2008
Record last verified: 2008-06