Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000153314
Ethics application status
Not yet submitted
Date submitted
18/03/2008
Date registered
31/03/2008
Date last updated
31/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the role of tumour-associated macrophages in the development and progression of lung cancer
Scientific title
Investigation of the role of tumour-associated macrophages in the development and progression of lung cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 2936 0
Condition category
Condition code
Cancer 3075 3075 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Bronchoalveolar lavage (BAL) of lung of patients undergoing bronchoscopy for suspected lung cancer / Lung resected for management of known lung cancer. BAL involves installation of a small amount of saline into the lung, via the bronchoscope, then removing the fluid via suctino to allow diagnosis of cells retrieved within the fluid. This is a standard diagnostic procedure in bronchoscopy.
Analysis of the behaviour of inflammatory cells in lung cancer, specifically, the role tumour-associated lung cancer play in the progression of lung cancer.
We hope to determine the diagnostic and prognostic value of such information
Intervention code [1] 2669 0
Early detection / Screening
Intervention code [2] 2670 0
Treatment: Other
Comparator / control treatment
Bronchoalveolar lavage (BAL) or wedge resection of adjacent lobe (for BAL) or non-tumour-bearing lung (for post-surgical specimens) to attain a "control" specimen
Control group
Active

Outcomes
Primary outcome [1] 3959 0
Sensitivity and specificity will be determined following analysis of both cell surface markers of alveolar macrophages, as well as characteristics (eg. phagocytic ability, inducible proteins). The ability of these to determine the diagnosis of cancer will be compared to the gold standard of histologic analysis of surgically resected specimen. Sensitivity (ability to detect a condition if it is present)/Specificity (how specific a positive result is for the particular condition being studied) of analysis of BAL inflammatory cells in determining the diagnosis of peripheral lung lesions.
Timepoint [1] 3959 0
36 months
Secondary outcome [1] 6659 0
Prognositc value of the presence/density/behaviour characteristics of inflammatory - ie. can information obtained from analysis predict whether patients will experience higher or lower rates of disease recurrence after surgery, or longer or shorter survival times following their diagnosis of lung cancer.
Timepoint [1] 6659 0
36 months

Eligibility
Key inclusion criteria
BAL - suspected lung cancer on the basis of radiologic imaging
Resection - known lung cancer, undergoing lung resection as treatment for known lung cancer
Minimum age
30 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known diagnosis of lung cancer
medical condition precludes bronchoscopy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3188 0
Government body
Name [1] 3188 0
National Health & Medical Research Council
Country [1] 3188 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan St
Melbourne Victoria 3050
Country
Australia
Secondary sponsor category [1] 2859 0
None
Name [1] 2859 0
Address [1] 2859 0
Country [1] 2859 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5174 0
Ethics committee address [1] 5174 0
Ethics committee country [1] 5174 0
Date submitted for ethics approval [1] 5174 0
31/03/2008
Approval date [1] 5174 0
Ethics approval number [1] 5174 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28445 0
Address 28445 0
Country 28445 0
Phone 28445 0
Fax 28445 0
Email 28445 0
Contact person for public queries
Name 11602 0
Dr Daniel Steinfort
Address 11602 0
c/- Department of Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Melbourne Victoria 3050
Country 11602 0
Australia
Phone 11602 0
+61 3 93427708
Fax 11602 0
Email 11602 0
[email protected]
Contact person for scientific queries
Name 2530 0
Dr Daniel Steinfort
Address 2530 0
c/- Department of Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Melbourne Victoria 3050
Country 2530 0
Australia
Phone 2530 0
+61 3 93427708
Fax 2530 0
Email 2530 0
[email protected]

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.