NCT00361647

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

2.3 years

First QC Date

August 7, 2006

Last Update Submit

June 10, 2008

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • 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.

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Paolo Prandoni, MD, PhD

    Department of Medical and Surgical Sciences, University of Padua, Italy

    PRINCIPAL INVESTIGATOR

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

Locations