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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 22 February 2013
Main ID:  ACTRN12607000514404
Date of registration: 09/10/2007
Primary sponsor: Hospital Royal Melbourne Hospital
Public title: Optimal method for the investigation of suspected lung cancer; Endobronchial Ultrasound versus Computerised Tomography (CT)-guided lung biopsy for the diagnosis of lung cancer.
Scientific title: Approach to the investigation of lung cancer; A Randomized Controlled Trial of Endobronchial Ultrasound versus CT-guided Core Needle Biopsy for the diagnosis & staging of lung cancer.
Date of first enrolment: 1/02/2008
Target sample size: 180
Recruitment status: Not yet recruiting
URL:  http://www.anzctr.org.au/ACTRN12607000514404.aspx
Study type:  Interventional
Study design:  Randomised controlled trial  Parallel
Countries of recruitment
Australia
Contacts
Name:   Dr Daniel Steinfort
Address:  c/- Department of Respiratory Medicine Royal Melbourne Hospital Grattan St Parkville 3052, Australia
Telephone: 03 9342 7708
Email: daniel.steinfort@mh.org.au
Affiliation: 
Name:   Dr Daniel Steinfort
Address:  c/- Department of Respiratory Medicine Royal Melbourne Hospital Grattan St Parkville 3052, Australia
Telephone: 03 9342 7708
Email: daniel.steinfort@mh.org.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: All patients referred to multidisciplinary lung clinic for evaluation and investigation of a solitary pulmonary nodule OR suspected lung cancer
Exclusion criteria: 1.clinical condition precludes investigation
2.Lesions <2cm diameter within 1cm of pleura
3.lesion <1cm diameter anywhere in lung fields
4.Evidence on CT scan of central (endobronchially visible) lesion
5.Other clinical site of disease more amenable to tissue diagnosis
6.Tissue diagnosis considered unnecessary by MDC team
7.Known current diagnosis of lung cancer


Age minimum: -2147483648 No limit
Age maximum: -2147483648 No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Patients with pulmonary nodules or suspected lung cancer
Intervention(s)
Patients will be randomized to undergo either Endobronchial Ultrasound or CT-guided core needle biopsy for the investigation of lung nodules/suspected lung cancer. Once the procedure (each will take approximately 20 minutes to perform) is completed their involvement in the trial will conclude.
Primary Outcome(s)
Diagnostic yield
pneumothorax rate
Secondary Outcome(s)
Radiation dosage received
staging information attained by procedure
Secondary ID(s)
Source(s) of Monetary Support
National Health and Medical Research Council
Secondary Sponsor(s)
NHMRC
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