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Trial registered on ANZCTR
Registration number
ACTRN12620000757910
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
23/07/2020
Date last updated
7/09/2023
Date data sharing statement initially provided
23/07/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Functional imaging-guided radiotherapy dose escalation in rectal adenocarcinoma: a feasibility study
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Scientific title
Functional imaging-guided radiotherapy dose escalation in rectal adenocarcinoma: a feasibility study
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Secondary ID [1]
301310
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
FIGURE-rectal
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rectal cancer
317495
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Condition category
Condition code
Cancer
315596
315596
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will evaluate the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer.
Patients will undergo pre-treatment MRI in the fortnight prior to commencing radiotherapy (+/- chemotherapy). Boost volume will be defined quantitatively according to intratumoural apparent diffusion coefficient (ADC) value. This volume will be targeted for a single-fraction 5-10Gy boost 3-5 days prior to commencing standard radiotherapy (50Gy delivered in 25 fractions).
Treatment will be administered by the Radiation Oncology department at Sunshine Coast University Hospital (SCUH), Birtinya. Each treatment takes approximately 15 minutes per day. Patients will be reviewed once per week by radiation oncology medical staff as per normal practice. Patients will also be asked to complete a quality of life questionnaire at several timepoints prior to, during and following completion of the treatment course, which will take an additional 5-10 minutes on each occasion.
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Intervention code [1]
317610
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
323833
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Rate of radiotherapy-related treatment toxicity as per Common Terminology Criteria for Adverse Events v5.0
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Assessment method [1]
323833
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Timepoint [1]
323833
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Acute toxicity: throughout and up to 3 months after treatment
Late toxicity: assessed at 3-12 monthly intervals after completion of treatment
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Secondary outcome [1]
383009
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Rate of pathological complete response
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Assessment method [1]
383009
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Timepoint [1]
383009
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Histopathological assessment at time of surgery (>8 weeks after completion of radiotherapy)
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Secondary outcome [2]
383010
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Quality of life (assessed with EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires)
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Assessment method [2]
383010
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Timepoint [2]
383010
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Prior to commencing radiotherapy; during week 3 of radiotherapy; during final week of radiotherapy; pre- and post-surgery; then at post-treatment follow-up at 6-12 monthly intervals for up to 36 months.
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Secondary outcome [3]
383011
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Overall survival (from start of treatment to all-cause mortality)
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Assessment method [3]
383011
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Timepoint [3]
383011
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Assessed during routine follow-up (3-12 monthly intervals for 36 months)
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Secondary outcome [4]
383012
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Locoregional recurrence-free survival (from start of treatment to clinical or radiological evidence of locoregional recurrence)
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Assessment method [4]
383012
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Timepoint [4]
383012
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Assessed during routine follow-up (3-12 monthly intervals for 36 months)
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Secondary outcome [5]
383013
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Disease-free survival (from start of treatment to radiological, clinical or biochemical evidence of local or distant disease recurrence/progression)
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Assessment method [5]
383013
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Timepoint [5]
383013
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Assessed during routine follow-up (3-12 monthly intervals for 36 months)
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Secondary outcome [6]
383018
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Surgical morbidity as per review of inpatient notes and surgical follow up notes
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Assessment method [6]
383018
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Timepoint [6]
383018
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Assessed from time of surgery to 3 months post-surgery
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Secondary outcome [7]
383384
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Surgical mortality as per review of inpatient notes and surgical follow up notes
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Assessment method [7]
383384
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Timepoint [7]
383384
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Assessed from time of surgery to 3 months post-surgery
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Eligibility
Key inclusion criteria
- Able to give informed consent
- Histologically-proven primary rectal adenocarcinoma within 0-10cm of anorectal junction on MRI or enteroscopy (T3, T4 or node positive disease with no evidence of metastatic spread (M0) on staging CT-chest/abdomen/pelvis (i.e. stage II/III disease))
- Patient undergoing curative intent neoadjuvant radiotherapy +/- chemotherapy
-- Neoadjuvant radiotherapy must be first component of neoadjuvant therapy (i.e. no induction course)
-- Concurrent chemotherapy can include capecitabine or fluorouracil
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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
- Contraindication to MRI studies (e.g. significant claustrophobia, incompatible pacemaker/implantable defibrillator, implanted metals)
- Patients receiving total neoadjuvant chemotherapy
- Significant imaging artefact precluding accurate MRI-guided radiotherapy planning (bilateral hip replacement etc.)
- Previous radiotherapy to pelvis
- Other malignancy conferring life expectancy of less than 3 years
- Pregnancy
- Active inflammatory bowel disease
- Prior diagnosis of connective tissue disorder
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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)
Not applicable
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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
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Descriptive reporting of toxicity, pathological response, quality of life measures. Kaplan-Meier analysis of survival outcomes (at 12, 24 and 36 months).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/03/2023
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Actual
10/07/2023
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Date of last participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last data collection
Anticipated
1/07/2027
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Actual
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Sample size
Target
30
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Accrual to date
2
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
16695
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Sunshine Coast University Hospital - Birtinya
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Recruitment postcode(s) [1]
30293
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4575 - Birtinya
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Funding & Sponsors
Funding source category [1]
305747
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Hospital
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Name [1]
305747
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Sunshine Coast University Hospital
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Address [1]
305747
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6 Doherty St
Birtinya
QLD 4575
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Country [1]
305747
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Australia
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Funding source category [2]
305748
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University
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Name [2]
305748
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University of the Sunshine Coast
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Address [2]
305748
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90 Sippy Downs Drive
Sippy Downs
QLD 4556
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Country [2]
305748
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Australia
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Primary sponsor type
Individual
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Name
Dr Myo Min
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Address
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya, QLD 4575
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Country
Australia
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Secondary sponsor category [1]
306177
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Individual
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Name [1]
306177
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Dr Nathan Hearn
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Address [1]
306177
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Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya, QLD 4575
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Country [1]
306177
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306022
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The Prince Charles Hospital HREC
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Ethics committee address [1]
306022
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The Prince Charles Hospital, Building 14, Rode Road, Chermside QLD 4032
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Ethics committee country [1]
306022
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Australia
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Date submitted for ethics approval [1]
306022
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Approval date [1]
306022
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02/03/2020
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Ethics approval number [1]
306022
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HREA/2020/QPCH/60803
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Summary
Brief summary
The aim of this study to assess the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer.
Who is it for?
Patients older than 18 years of age, with rectal cancer confirmed on biopsy, undergoing curative-intent neoadjuvant radiotherapy (+/- chemotherapy) may be eligible for this study.
Study details
Participation in this trial will require undergoing an additional MRI scan prior to starting treatment; one extra day of treatment prior to the usual 5-6 weeks of radiotherapy; and completion of brief quality of life questionnaires before, during and after treatment.
A key part of the study is also to assess any treatment-related toxicity and your quality of life during and after treatment to ensure the additional dose does not have any adverse effects.
It is hoped that this research will help to improve proportion of patients that completely respond to radiation treatment given with concurrent chemotherapy and therefore reduce the need for surgery for 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
102450
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Dr Myo Min
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Address
102450
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Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
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Country
102450
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Australia
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Phone
102450
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+61 7 5202 1111
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Fax
102450
0
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Email
102450
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[email protected]
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Contact person for public queries
Name
102451
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Dr Myo Min
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Address
102451
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Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
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Country
102451
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Australia
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Phone
102451
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+61 7 5202 1111
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Fax
102451
0
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Email
102451
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[email protected]
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Contact person for scientific queries
Name
102452
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Dr Myo Min
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Address
102452
0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
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Country
102452
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Australia
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Phone
102452
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+61 7 5202 1111
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Fax
102452
0
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Email
102452
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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
For confidentiality reasons
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7973
Informed consent form
The consent form will be available from the study ...
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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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