Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000514404
Ethics application status
Not yet submitted
Date submitted
27/09/2007
Date registered
9/10/2007
Date last updated
9/10/2007
Type of registration
Prospectively registered

Titles & IDs
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with pulmonary nodules or suspected lung cancer 2404 0
Condition category
Condition code
Respiratory 2508 2508 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2126 0
Diagnosis / Prognosis
Comparator / control treatment
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.
Control group
Active

Outcomes
Primary outcome [1] 3404 0
Diagnostic yield
Timepoint [1] 3404 0
Immediatley following investigative procedure
Primary outcome [2] 3405 0
pneumothorax rate
Timepoint [2] 3405 0
Time of investigative procedure
Secondary outcome [1] 5662 0
staging information attained by procedure
Timepoint [1] 5662 0
At time of investigative procedure
Secondary outcome [2] 5663 0
Radiation dosage received
Timepoint [2] 5663 0
At time of investigative procedure

Eligibility
Key inclusion criteria
All patients referred to multidisciplinary lung clinic for evaluation and investigation of a solitary pulmonary nodule OR suspected lung cancer
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be identified and consent to enrollment before randomization to either active group for investigation. Randomization will be by centralized computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 271 0
3052

Funding & Sponsors
Funding source category [1] 2654 0
Government body
Name [1] 2654 0
National Health and Medical Research Council
Country [1] 2654 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
c/- Department of Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville 3052
Country
Australia
Secondary sponsor category [1] 2402 0
Government body
Name [1] 2402 0
NHMRC
Address [1] 2402 0
GPO Box 1421
Canberra ACT 2601
Country [1] 2402 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4574 0
Ethics committee address [1] 4574 0
Ethics committee country [1] 4574 0
Date submitted for ethics approval [1] 4574 0
03/10/2007
Approval date [1] 4574 0
Ethics approval number [1] 4574 0
2007.224
Ethics committee name [2] 4605 0
Ethics committee address [2] 4605 0
Ethics committee country [2] 4605 0
Date submitted for ethics approval [2] 4605 0
03/10/2007
Approval date [2] 4605 0
Ethics approval number [2] 4605 0

Summary
Brief summary
The purpose of this project is to determine what is the most appropriate method of investigation of lung masses, or suspected lung cancer. Currently there is no guidance for clinicians as to which of the two commonest methods (bronchoscopy or CT-guided lung biopsy) is optimal. Our study hopes to determine if one of these two diagnostic procedures is more appropriate than the other in investigating patients with lung masses or suspected lung cancer. While either may be performed at present, there is no information to guide clinicians as to particular clinical features that may make one procedure more beneficial than the other, both in terms of maximizing the rate of achieving a diagnosis and also in minimizing the rate of complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28075 0
Address 28075 0
Country 28075 0
Phone 28075 0
Fax 28075 0
Email 28075 0
Contact person for public queries
Name 11232 0
Dr Daniel Steinfort
Address 11232 0
c/- Department of Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville 3052
Country 11232 0
Australia
Phone 11232 0
03 9342 7708
Fax 11232 0
03 9342 8493
Email 11232 0
daniel.steinfort@mh.org.au
Contact person for scientific queries
Name 2160 0
Dr Daniel Steinfort
Address 2160 0
c/- Department of Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville 3052
Country 2160 0
Australia
Phone 2160 0
03 9342 7708
Fax 2160 0
03 9342 8493
Email 2160 0
daniel.steinfort@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.