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Trial registered on ANZCTR
Registration number
ACTRN12619000680167
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
7/05/2019
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Very low-energy diet before surgery in obese patients undergoing partial liver excision: a pilot randomised control trial (Very SuPPLE Trial)
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Scientific title
Very low-energy diet before surgery in obese patients undergoing partial liver excision: a pilot randomised control trial (Very SuPPLE Trial)
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Secondary ID [1]
298061
0
none
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Universal Trial Number (UTN)
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Trial acronym
Very SuPPLE Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver Cancer
312557
0
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Obesity
312655
0
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Condition category
Condition code
Cancer
311076
311076
0
0
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Liver
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Diet and Nutrition
311150
311150
0
0
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Obesity
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Surgery
311151
311151
0
0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants in the intervention group will be provided Optifast by their consulting physician and given a food diary. The two weeks’ worth of Optifast (Optifast milkshakes), which consists of three replacement meals (150 kcal per meal replacement) per day, will be given to the patient and they will be advised of the daily water requirements and other low calorie they should include to provide a total daily energy intake of approximately 800 kcal (3.3MJ).
Trial participants have a water requirement of at least 2 litres of fluid including the VLED every day. This amounts to 8 cups of water, milk-free tea or coffee, low calorie soft drink, low calorie cordial every day. The only additional foods permitted include low calorie jelly, strained broth and certain vegetables. A teaspoon of vegetable or olive oil to the vegetable intake each day will be required to assist with gall bladder contraction in the absence of additional fat in the diet. The required water and the optional additional broth / vegetables will be provided by the participants.
Participants will also complete a baseline QOL questionnaire
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Intervention code [1]
314320
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Treatment: Other
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Comparator / control treatment
This group will receive routine preoperative care as part of their cancer treatment from diagnosis to liver surgery. While it is common to encourage patients with high BMI to lose weight, no specific encouragement of a VLCD program will be discussed. These participants will also be provided a food diary and encouraged to complete it truthfully. Participants will also complete a baseline QOL questionnaire
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Control group
Active
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Outcomes
Primary outcome [1]
319889
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Feasibility:
Composite primary outcome, conisisting of feasibility of patients undergoing a two-week trial of VLCD will be assessed by the recruitment, retention and adherence of the participants. The recruitment will be calculated by the number of eligible participants recruited. Retention will be assessed by the proportion of patients in the intervention arm able to complete the intervention and adherence will be calculated by the percentage of the two-week VLCD regimen that was able to be completed from food record diaries.
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Assessment method [1]
319889
0
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Timepoint [1]
319889
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at end of study period
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Secondary outcome [1]
369788
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Assessment of change in liver size using ultrasound-guided elastography.
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Assessment method [1]
369788
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Timepoint [1]
369788
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baseline and 2-weeks post intervention
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Secondary outcome [2]
369790
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To assess is the use of VLED/VLCD impacts patient's Quality of life using the SF-36
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Assessment method [2]
369790
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Timepoint [2]
369790
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baseline, 2 weeks post intervention & 3 months post surgery
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Secondary outcome [3]
369794
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To assess if the use of VLCD/VLED makes surgery technically easier. This will be assessed using the NASA TLX
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Assessment method [3]
369794
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Timepoint [3]
369794
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immediately post-surgery
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Secondary outcome [4]
369815
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Assessment of the cost-effectiveness of trial. Measured using the AQoL-8D and Labour Force survey
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Assessment method [4]
369815
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Timepoint [4]
369815
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at time of discharge
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Secondary outcome [5]
369897
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Assessment of change in liver steatosis with ultrasound-guided elastography.
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Assessment method [5]
369897
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Timepoint [5]
369897
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At baseline and at surgery
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Secondary outcome [6]
369898
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Number of blood transfusion from medical records.
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Assessment method [6]
369898
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Timepoint [6]
369898
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within 48hrs of surgery
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Secondary outcome [7]
369899
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post-operative liver failure (defined as the impaired ability of the liver to maintain it synthetic, excretory and detoxifying function characterised by increased international normalized ratio and concomitant hyperbilirubinemia). from medical records
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Assessment method [7]
369899
0
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Timepoint [7]
369899
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post-surgery to discharge
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Secondary outcome [8]
369900
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bile leakage (defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis). from medical records
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Assessment method [8]
369900
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Timepoint [8]
369900
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post-surgery to discharge
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Secondary outcome [9]
369901
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reoperation, from medical records
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Assessment method [9]
369901
0
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Timepoint [9]
369901
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30 days post surgery
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Secondary outcome [10]
369902
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death as noted in medical records
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Assessment method [10]
369902
0
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Timepoint [10]
369902
0
30 days post surgery
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Secondary outcome [11]
369903
0
presence of clear margins in the histopathological specimen , as noted in medical records
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Assessment method [11]
369903
0
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Timepoint [11]
369903
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post-surgery
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Eligibility
Key inclusion criteria
(i) Body Mass Index (BMI) >30 (obese); or a BMI >27 and a waist circumference in obese range (Caucasian – female >88cm, male >102cm; Asian/Aboriginal – female >30cm, male >90cm)
(ii) Undergoing liver resection surgery
(iii) Presenting to an Upper Gastrointestinal surgeon 2 week prior to surgery.
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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
(i) Clinically malnourished
(ii) Pregnant or breastfeeding
(iii) Have a comorbidity which prohibits restrictive dieting (in consultation with an endocrinologist), or a contra-indication to VLED (eg porphyria, recent myocardial infarction, unstable angina)
(iv) Have a contraindication to (ICG) (iodine hypersensitivity, dialysis, renal failure)
(v) Have cognitive impairment such as they cannot give consent, or
(vi) Have inadequate English language skills to understand the intervention/ study.
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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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out on a 1:1 basis by a computer-based random sequence generator in the REDCap System. Variable sized blocks will be used to ensure approximately equal numbers in the two trial arms. Participants will be stratified on if they chemotherapy or not prior to intervention.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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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
Efficacy
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Statistical methods / analysis
The proportion of patients who consent to the study and reasons for non-consent will be summarised. Characteristics of patients randomised to each group will be compared. The number of and percentage of the intervention group who commenced and completed the program will be calculated. Those who did not complete the full program, the reasons for not completing treatment preoperatively will be analysed. Secondary outcomes will be compared between control and intervention groups. ICG clearance and US elastography will be compared before and after the VLED. Immediate peri-operative ICG clearance and US elastography results will be compared to histopathological results of peri-tumoral liver tissue (i.e. background liver tissue) to assess for any correlation. The six clinical outcomes outlined above will be compared between intervention and control groups
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/05/2019
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
13672
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Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
26354
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2050 - Camperdown
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Funding & Sponsors
Funding source category [1]
302594
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University
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Name [1]
302594
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Central Clinical School; University of Sydney
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Address [1]
302594
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Room 5214, Level 2, Medical Foundation Building (K25) 92-95 Parramatta Road, Camperdown NSW 2050
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Country [1]
302594
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Australia
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Primary sponsor type
Government body
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Name
Sydney Local Health District
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Address
Executive Offices
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
302545
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None
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Name [1]
302545
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Address [1]
302545
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Country [1]
302545
0
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Other collaborator category [1]
280657
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Other
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Name [1]
280657
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Surgical Outcomes Research Centre
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Address [1]
280657
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Level 9, Building 89
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Mailing address:
PO Box M157
Missenden Road
Camperdown, NSW 2050
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Country [1]
280657
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303229
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Sydney Local Health District (RPAh Zone)
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Ethics committee address [1]
303229
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Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
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Ethics committee country [1]
303229
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Australia
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Date submitted for ethics approval [1]
303229
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Approval date [1]
303229
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21/02/2019
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Ethics approval number [1]
303229
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X18-0233 & HREC/18/RPAH/314
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Summary
Brief summary
The purpose of this study is to determine if it is possible to use a very low calorie diet in obese patients prior to surgery.
Who is it for?
You may be eligible for this study if you are an overweight adult who is undergoing surgery to remove all or part of your liver.
Study details
Participants in this study will be randomly selected to undergo one of the following:
Group 1: participants in this group will be required to undergo a very low calorie diet for 2 weeks prior to their surgery, including 3 replacement meals per day.
Group 2: participants in this group will continue with routine preoperative care with their physician.
All participants will have will have an ultrasound elastography to measure Liver stiffness (steatosis) and liver size, and will have an ICG Clearance test to investigate liver function.
It is hoped that this research will help determine if very low calorie diets can be completed by participants in the 2 weeks prior to their surgery, and whether the low calorie diet has any effect on surgery outcomes.
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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
92930
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Dr David Yeo
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Address
92930
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mail to: Suite 1 54-60 Briggs Street Camperdown NSW 2050
Royal Prince Alfred Hospital
Missenden Road, Camperdown NSW 2050
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Country
92930
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Australia
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Phone
92930
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+61 28937 2213
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Fax
92930
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Email
92930
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[email protected]
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Contact person for public queries
Name
92931
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Dr David Yeo
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Address
92931
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mail to: Suite 1 54-60 Briggs Street Camperdown NSW 2050
Royal Prince Alfred Hospital
Missenden Road, Camperdown NSW 2050
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Country
92931
0
Australia
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Phone
92931
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+61 28937 2213
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Fax
92931
0
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Email
92931
0
[email protected]
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Contact person for scientific queries
Name
92932
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Dr David Yeo
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Address
92932
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mail to: Suite 1 54-60 Briggs Street Camperdown NSW 2050
Royal Prince Alfred Hospital
Missenden Road, Camperdown NSW 2050
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Country
92932
0
Australia
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Phone
92932
0
+61 28937 2213
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Fax
92932
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Email
92932
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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)?
Yes
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What data in particular will be shared?
De-identified individual participant data underlying published results only
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
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Available to whom?
Only researchers who provide a methodologically sound proposal on a case-by-case basis at the discretion of Primary Sponsor and Chief investigators
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Available for what types of analyses?
Only to achieve the aims in the approved proposal.
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How or where can data be obtained?
Access will be subject to approvals by Principal Investigator and approved proposals will require a signed data access agreement.
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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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