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Trial registered on ANZCTR
Registration number
ACTRN12624001188527p
Ethics application status
Submitted, not yet approved
Date submitted
2/08/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
G-DISCO: A Phase 1 study of feasibility, safety and tolerability of synchronous intravesical administration of gemcitabine and docetaxel - ANZUP 2403.
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Scientific title
G-DISCO: A Phase 1 study of feasibility, safety and tolerability of synchronous intravesical administration of gemcitabine and docetaxel - ANZUP 2403.
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Secondary ID [1]
312640
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ANZUP 2403
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Universal Trial Number (UTN)
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Trial acronym
G-DISCO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
High risk non muscle invasive bladder cancer
334606
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Condition category
Condition code
Cancer
331191
331191
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0
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Bladder
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will undergo synchronous intravesical administration of gemcitabine and docetaxel for treatment of high risk non muscle invasive bladder cancer.
Participants will be administered 1g gemcitabine and 37.5mg of docetaxel constituted together in 50mls of saline for a minimum recommended dwell time of 60 minutes and optimum dwell time of 90 minutes.
Participants will undergo the synchronous administration of gemcitabine and docetaxel at the Day Procedure Unit, under the care of Urology. This treatment regime will be administered by nursing staff once a week for six weeks. Participants will remain in the Day Procedure Unit for the duration of the dwell time (between 60 and 90 minutes) and will remain under the observation of Day Procedure Unit nursing staff. At the completion of the dwell time participants will void in the Day Procedure Unit before leaving.
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Intervention code [1]
329157
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Treatment: Drugs
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Comparator / control treatment
This is a single arm trial with no comparator or control arm.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility of synchronous administration of intravesical gemcitabine and docetaxel
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Assessment method [1]
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Completion rates of planned 6 week course of intravesical gemcitabine and docetaxel. Completion rates will be determined by review of patient electronic medical records.
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Timepoint [1]
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At completion of six weekly treatment regime
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Primary outcome [2]
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Safety of synchronous administration of intravesical gemcitabine and docetaxel
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Assessment method [2]
339249
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Adverse event assessment using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Known side effects of intravesical treatment are bladder inflammation (cystitis) and haematuria
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Timepoint [2]
339249
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Weekly assessment of adverse events over the six week treatment regime
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Primary outcome [3]
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Tolerability of synchronous administration of intravesical gemcitabine and docetaxel
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Assessment method [3]
339250
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Patient reported outcome measures (PROM):
Non Muscle Invasive Bladder Cancer Symptom Index questionnaire (NMIBC-SI)
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Timepoint [3]
339250
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Weekly assessment over the six week treatment regime
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Secondary outcome [1]
438243
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Recurrence rates at 3 months
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Assessment method [1]
438243
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Approximately six weeks after completion of the six weekly treatment regime, participants will undergo rigid cystoscopy and bladder biopsies to assess for treatment response (three months after commencement of treatment).
Analysis of histopathology reports from bladder biopsies taken after completion of six weekly treatments of synchronous intravesical gemcitabine and docetaxel (three months from commencement of treatment.).
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Timepoint [1]
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Three months after commencement of treatment
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Secondary outcome [2]
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Carbon footprint - comparison of synchronous verses sequential administration of combination intravesical chemotherapy
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Assessment method [2]
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Identification of carbon footprint for all healthcare encounters (inputs) for preparation and administration of combination intravesical chemotherapy. This analysis will calculate the actual carbon footprint of participants who undergo the trial synchronous combination intravesical gemcitabine and docetaxel. A calculation will also be made of the theoretical carbon footprint generated by sequential combination intravesical gemcitabine and docetaxel for comparison with the trial generated carbon footprint.
This analysis will be completed using tools such as the Climate Impact Checkup tool and Care Pathways Carbon Footprint Calculator.
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Timepoint [2]
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At completion of six week treatment regime
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Secondary outcome [3]
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Translational sub-study:
Pharmacokinetics of systemic absorption of gemcitabine and docetaxel
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Assessment method [3]
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Pharmacokinetic analysis - serum concentrations of gemcitabine and docetaxel 1 hour after administration (Cmax)
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Timepoint [3]
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Pharmacokinetic analysis - blood sample collected one hour after synchronous administration of gemcitabine and docetaxel. Blood sample will be collected after the first weekly treatment.
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Secondary outcome [4]
439662
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Tolerability of synchronous administration of intravesical gemcitabine and docetaxel - this is an additional primary outcome
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Assessment method [4]
439662
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Patient reported outcome measures (PROM):
American Urological Association (AUA) Symptom Index score / International Prostate Symptom Score (IPSS)
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Timepoint [4]
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Weekly for the duration of the six weekly treatment regime
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Secondary outcome [5]
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Translational sub-study:
Sub-typing of archival bladder tissue into luminal vs basal groups for correlation against response rates
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Assessment method [5]
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Tumour sub-typing into basal or luminal - immunohistochemistry staining of archival bladder tumour tissue. Tissue sub-type will then be correlated with response to treatment as indicated by the histopathology of the end of six week treatment bladder biopsy result
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Timepoint [5]
439663
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Tumour subtyping - at completion of study - three months after completion of six weekly treatment instillations
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Eligibility
Key inclusion criteria
Inclusion Criteria:
1. Fully resected, high-risk, non-muscle-invasive bladder cancer (HRNMIBC) - (carcinoma in situ (CIS) allowed))
2. Disease unresponsive to intravesical therapy, to include:
a) Bacille Calmette-Guerin (BCG) unresponsive disease* despite adequate** BCG therapy
b) HRNMIBC where BCG is contra-indicated or unsuitable
c) Unresponsive disease to prior intra-vesical chemotherapy in patients where BCG is either unsuitable or unavailable
d) Persistent or recurrent high-grade disease after a less than adequate course of intravesical therapy, in patients considered not suitable for further intravesical therapy
3. Unsuitable for, or patient declining, radical cystectomy
4. Age 18 years and over
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2
6. Life expectancy > 6 months
7. Adequate organ and bone marrow function
*BCG-unresponsive disease - is defined as at least one of:
i. Persistent or recurrent CIS +/- Ta/1 within 12 months of completion of adequate BCG therapy
ii. Recurrent high-grade Ta/1 within 6 months of completion of adequate BCG therapy
iii. High-grade T1 at the first evaluation following an induction BCG course
**An adequate BCG course - is defined as at least five doses of an induction course, plus at least two further doses (maintenance or second induction) of BCG. This definition applies regardless of issues relating to BCG timing, dosing, and strain.
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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
Exclusion Criteria:
1. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade equal to or greater than 2 from previous anti-cancer therapy
2. History of allogenic organ transplantation
3. Current or prior documented autoimmune or inflammatory disorders
4. History of another primary malignancy within the last 5 years, excluding non-melanomatous skin cancer
5. History of active primary immunodeficiency
6. Active tuberculosis, hepatitis b, or hepatitis c
7. Current use of immunosuppressive medications
8. Female patients who are pregnant or breastfeeding, or male or female patients who are not willing to employ effective birth control during treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/10/2024
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Actual
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Date of last participant enrolment
Anticipated
26/10/2026
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Actual
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Date of last data collection
Anticipated
31/03/2027
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
317073
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Other Collaborative groups
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Name [1]
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Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group
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Address [1]
317073
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Country [1]
317073
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Australia
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Primary sponsor type
Government body
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Name
South Metropolitan Health Service
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Address
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Country
Australia
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Secondary sponsor category [1]
319365
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None
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Name [1]
319365
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Address [1]
319365
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Country [1]
319365
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315822
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
315822
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
315822
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Australia
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Date submitted for ethics approval [1]
315822
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30/07/2024
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Approval date [1]
315822
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Ethics approval number [1]
315822
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Summary
Brief summary
The purpose of this project is to assess the feasibility, safety and tolerability of synchronous intravesical instillation of gemcitabine and docetaxel for this cohort of patients. Who is it for? Participants are eligible for this study if they are over the age of 18 with confirmed fully resected, high-risk, non-muscle-invasive bladder cancer where BCG treatment has been unsuccessful or cannot be given. Study details Participants will undergo synchronous intravesical administration of gemcitabine and docetaxel. The planned treatment schedule is once a week for six weeks. Participants will then be tested weekly for completion, adverse events, patient-reported outcome, and 3 months recurrence. Translational studies on a small sample of blood collected after the first weekly treatment and on existing bladder tumour specimens will be performed if consent is given. It is hoped that findings from this study will help improve the health outcomes for people with high risk non muscle invasive bladder cancer by providing an alternative treatment option to removal of the bladder when BCG is unsuccessful or cannot be given.
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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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Prof Dickon Hayne
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Address
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Fiona Stanley Hospital , 11 Robin Warren Drive, Murdoch WA 6150
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Country
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Australia
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Phone
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+61 08 6152 1130
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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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Cynthia Hawks
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Address
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Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150
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Country
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Australia
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Phone
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+61 08 6151 1139
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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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Dickon Hayne
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Address
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Fiona Stanley Hospital. 11 Robin Warren Drive, Murdoch WA 6150
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Country
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Australia
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Phone
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+61 08 6152 1130
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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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