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Trial registered on ANZCTR
Registration number
ACTRN12624000951550p
Ethics application status
Not yet submitted
Date submitted
18/06/2024
Date registered
6/08/2024
Date last updated
6/08/2024
Date data sharing statement initially provided
6/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Robotic vs Standard Keyhole Surgery for Early-Stage Lung Cancer: An Australian Randomised Controlled Trial (RAVAL)
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Scientific title
Robotic vs Thoracoscopic Surgical Resection for Early-Stage Lung cancer: An Australian Randomised Controlled Trial (RAVAL)
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Secondary ID [1]
312350
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
This trial is related to NCT02617186 (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early-Stage Lung Cancer: A Randomized Controlled Trial being conducted in Canada and France. The Australian version of this study is also examining a broader range of resections including bi-lobectomy, extended lobectomy, simple lobectomy or segmentectomy.
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
334124
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Condition category
Condition code
Cancer
330796
330796
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0
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Trial is evaluating Robotic surgery for resection of their early-stage lung cancer. Surgery will be performed by a qualified thoracic surgeon and the surgery will take up to 3 hours. This is a standard of care treatment of lung cancer currently via keyhole surgery where the surgeon operates the instruments robotically. The trial will be evaluating the short-term outcomes post-surgery (compared to VATS [Video-Assisted Thoracic Surgery] resection) such as length of surgery, complications, length of post operative hospitalisation, and will also evaluate quality of life post-surgery.
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Intervention code [1]
328845
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Treatment: Surgery
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Comparator / control treatment
Trial is evaluating standard video-assisted thoracoscopic surgery for resection of their early-stage lung cancer. This is a standard of care treatment of lung cancer currently via keyhole surgery where the surgeon operates the instruments manually. The surgery typically takes up to 3 hours and will be performed by a specialist thoracic surgeon. The trial will be evaluating the short-term outcomes post-surgery (compared to robotic resection) such as length of surgery, complications, length of post operative hospitalisation, and will also evaluate quality of life post-surgery.
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Control group
Active
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Outcomes
Primary outcome [1]
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The trial is intended to determine the difference in participant-reported HRQOL outcomes between RTS-Lobectomy and VATS-Lobectomy at 12 weeks.
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Assessment method [1]
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Health related Quality of Life (HRQOL).
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Timepoint [1]
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12 weeks post surgery.
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Secondary outcome [1]
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Difference in quality of life between the treatment groups, as measured by which coincide with standard of care intervals of oncological surveillance.
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Assessment method [1]
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The Health-Related Quality of Life questionnaire
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Timepoint [1]
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Weeks 3 and 7 and 12; months 6, 12, 18, 24; and years 3, 4, and 5,
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Secondary outcome [2]
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5-year survival rate
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Assessment method [2]
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Survival data via patient follow-up
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Timepoint [2]
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5 years post surgery.
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Secondary outcome [3]
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Determination of higher quality pathological staging by improved lymphadenectomy.
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Assessment method [3]
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Anatomical pathological assessment
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Timepoint [3]
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Time of surgery.
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Secondary outcome [4]
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Duration of surgery between RTS- Lobectomy vs VATS- Lobectomy
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Assessment method [4]
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Duration of surgery between RTS- Lobectomy vs VATS- Lobectomy will be compared.
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Timepoint [4]
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At completion of surgery
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Secondary outcome [5]
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Amount of intraoperative blood loss with RTS-Lobectomy.
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Assessment method [5]
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Calculation of total blood loss of VATS-Lobectomy will be compared with RTS-Lobectomy
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Timepoint [5]
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At completion of surgery.
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Secondary outcome [6]
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Post-operative analgesia requirements between RTS-Lobectomy vs VATS-Lobectomy.
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Assessment method [6]
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The analgesia requirements between RTS-Lobectomy vs VATS-Lobectomy will be compared.
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Timepoint [6]
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During the duration of stay in hospital and post discharge.
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Secondary outcome [7]
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Length of chest tube drainage required
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Assessment method [7]
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Days of chest tube drainage required
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Timepoint [7]
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Hospital stay
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Secondary outcome [8]
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Duration of hospital stay
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Assessment method [8]
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Patient surgery till discharge date
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Timepoint [8]
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Hospitalisation
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Eligibility
Key inclusion criteria
• Age 18 years and above
• Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
• Candidates for minimally invasive pulmonary surgery, as determined by the operating surgeon.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Not a candidate for minimally invasive lobectomy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by surgeon. To ensure balance within local data and international data, there will also be stratification by procedure extent, viz. lobectomy or segmentectomy. Participants will be randomised using a web-based Research Electronic Data Capture (REDCap).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Baseline characteristics of both treatment groups will be compared to ensure homogeneity in the patient population. Descriptive statistics will be reported by treatment group where categorical variables will be reported as counts (percentages) and continuous variables as mean (standard deviation) or as median (25th percentile, 75th percentile). All analyses of primary and secondary outcomes will be carried out based on the intention-to-treat principle. Unadjusted comparisons of continuous outcome measures will be carried out using an independent t-test or the Wilcoxon rank-sum test if the assumptions of the t-test were violated. Unadjusted comparisons of categorical outcome measures will be computed using the chi-squared test, or the Fisher’s exact test if any of the expected values in the contingency table is less than 5, or McNemar’s test. For adjusted analyses multivariable logistic regression analyses will be used for binary outcomes and multivariable linear regression for continuous outcomes. The results of comparisons between groups will be presented as mean differences for continuous outcomes and relative risks or odds ratios for binary outcomes, with corresponding 95% confidence intervals and associated p-values.
Survival will be compared using the Kaplan-Meier method and cox proportional hazard models. Survival curves will be compared using the Log-rank test. P-values will be reported to three decimal places with p-values less than 0.001 reported as p < 0.001. All international analyses will be performed using SAS. Table 2 provides a summary of the variables, measures and methods of analysis. Local analyses will be performed using the R statistical package.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/08/2024
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Actual
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Date of last participant enrolment
Anticipated
2/08/2027
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Actual
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Date of last data collection
Anticipated
2/08/2032
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [2]
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St Vincent's Private Hospital - Fitzroy
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Recruitment hospital [3]
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [4]
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Eastern Health - Box Hill
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Recruitment postcode(s) [1]
42734
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St Vincent's Hospital Melbourne
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
318965
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Address [1]
318965
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Country [1]
318965
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
315526
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
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https://svhm.org.au/home/research/researchers/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/08/2024
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Approval date [1]
315526
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Ethics approval number [1]
315526
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Summary
Brief summary
This trial aims to determine if there is any difference in patient-reported health-related quality of life and other clinical outcomes for patients with early-stage non-small cell lung cancer (NSCLC) who will undergo surgical removal of their cancer by either robotic keyhole surgery (RTS) or video assisted keyhole surgery (VATS). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early-stage non-small cell lung cancer and you are able to undergo minimally invasive keyhole surgery for removal of your cancer. Your treating doctor will be able to review your lung images to determine whether this type of surgery is right for you. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to undergo surgery by one of two methods. Participants allocated to the first group will undergo robotic-assisted keyhole surgery, it is anticipated this procedure take up to 3 hours. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. Participants allocated to the second group will undergo video-assisted keyhole surgery, it is anticipated that this procedure will take up to 3 hours. During video-assisted keyhole surgery (VATS), the surgeon inserts a small camera into the lung that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Both types of surgery are currently standard of care to successfully remove lung cancer. It is expected that participants in both groups will need to stay in hospital after their surgery to ensure there are no unexpected complications. If you choose to participate in this study, the research team will ask to review your medical records prior to the surgery and for up to 5 years after the surgery to follow your progress. It is hoped this research will demonstrate any differences in patient outcomes following each type of surgery. If one surgical method is found to be more effective for removal of cancer and less painful for patients, the evidence gathered from this trial may be used to promote use of that surgical method for future cancer patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Gavin Wright
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Address
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St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
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Country
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Australia
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Phone
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+613 94192477
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jane Mack
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Address
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St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
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Country
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Australia
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Phone
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+613 9231 1618
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Gavin Wright
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Address
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St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
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Country
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Australia
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Phone
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+613 94192477
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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