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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06279260
Registration number
NCT06279260
Ethics application status
Date submitted
19/02/2024
Date registered
28/02/2024
Titles & IDs
Public title
National Robotics-Assisted Radical Prostatectomy Database
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Scientific title
National Robotics-Assisted Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcome Measures (PROMS)
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Secondary ID [1]
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104451/2023.295
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Universal Trial Number (UTN)
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Trial acronym
RASOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Database
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Prostate Cancer
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Robotic-assisted Radical Prostatectomy
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Surgical Outcomes
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Oncological Outcomes
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Patient Reported Outcome Measures
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Learning Curve
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To provide a standardized framework, enabling robust evidence strengthening & analyses, trend identification, and the formulation of evidence-based guidelines for the individualized management of PCa.
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Assessment method [1]
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Standardize notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.
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Timepoint [1]
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At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
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Secondary outcome [1]
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Patient reported quality of life outcome measures
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Assessment method [1]
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The first set of outcome variables will be the functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire
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Timepoint [1]
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At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
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Secondary outcome [2]
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Surgical
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Assessment method [2]
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The second set of outcome variables will gather detailed insights into surgical measures in In terms of operative and post-operative characteristics.
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Timepoint [2]
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At baseline, 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
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Secondary outcome [3]
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Oncological
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Assessment method [3]
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The third set of outcome variables will collect the oncological measures in terms of Biochemical re-occurrence and margin status.
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Timepoint [3]
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4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
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Eligibility
Key inclusion criteria
To be eligible to participate in this database, an individual must meet all of the following criteria:
1. Individuals who consent to participate,
2. within the age range of 18 to 90 years,
3. confirmed diagnosis of localized prostate cancer (PCa)
4. patients receiving medical attention at hospitals engaged in collaborative efforts with the designated database.
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participants are not eligible to take part in the database:
2. Individuals who have not undergone robotic surgery for prostatectomy or TP biopsy. ,
3. without a diagnosis of prostate cancer or
4. who decline to provide consent for the collection of their health information
5. Under the age of 18 years.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2024
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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
1/12/2050
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Actual
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Sample size
Target
10000
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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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Ballarat Health - Ballarat
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Recruitment hospital [2]
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Barwon health - Geelong
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Recruitment hospital [3]
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Austin Healthcare - Melbourne
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Recruitment hospital [4]
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E.J Whitten Prostate Cancer Centre, Epworth Healthcare - Melbourne
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Recruitment hospital [5]
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St. Vincent's Private Hospital - Melbourne
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Recruitment hospital [6]
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Western Heath - Melbourne
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Recruitment hospital [7]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [8]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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3350 - Ballarat
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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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2084 - Melbourne
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Recruitment postcode(s) [4]
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3002 - Melbourne
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Recruitment postcode(s) [5]
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3011 - Melbourne
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Recruitment postcode(s) [6]
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3050 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melbourne Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Peter MacCallum Cancer Centre, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Epworth Healthcare
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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St Vincent's Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Government body
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Name [4]
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Austin Health
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Address [4]
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Other collaborator category [5]
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Government body
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Name [5]
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Barwon Health
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Ballarat Health Services
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Address [6]
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Country [6]
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Other collaborator category [7]
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Government body
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Name [7]
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Western Health, Australia
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Address [7]
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Country [7]
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Ethics approval
Ethics application status
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Summary
Brief summary
In Australia, nearly 70 men are diagnosed with Prostate cancer every day. Prostate removal (Radical Prostatectomy) is the proven treatment option to control cancer spread. Most of the prostate removal surgeries are done using robots. Robotic assisted prostate removal surgeries have been invented to minimise the risk of side effects post-surgery. Doctors prefer the robots over open surgery as there are benefits to patients (shorter hospital stays, lesser blood loss and better quality of life) and surgeons (better dexterity, improved field of vision and less pain). However, the cost of the robot outweighs the benefits at present and there is very less information concerning the long-term outcomes for patients. Studies conducted so far are small scale studies and the results from these studies cannot be generalized to the population at large in Australia. So, there is need for a largescale study that will look at the long-term outcomes and the factors that impact robotic surgeries across the metropolitan and rural hospital sectors. Hence, this comprehensive database has been setup to collaborate with major hospitals, across metropolitan and rural areas in Australia. Through this database, researchers will be able to explore the diagnostic pathway for Prostate cancer and understand the long-term benefits of robotic surgery through patient reported questionnaires. Outcomes from this database will also help compare the quality of care against other powerhouses of robotic surgery. Eventually, the database aims to standardize diagnostic pathways and clinical notes that are the same across different hospitals conducting robotic-assisted surgeries for Prostatectomy and improve care for prostate cancer patients across the country.
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Trial website
https://clinicaltrials.gov/study/NCT06279260
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Trial related presentations / publications
Perera S, Fernando N, O'Brien J, Murphy D, Lawrentschuk N. Robotic-assisted radical prostatectomy: learning curves and outcomes from an Australian perspective. Prostate Int. 2023 Mar;11(1):51-57. doi: 10.1016/j.prnil.2022.10.002. Epub 2022 Oct 29. Fridriksson JO, Folkvaljon Y, Lundstrom KJ, Robinson D, Carlsson S, Stattin P. Long-term adverse effects after retropubic and robot-assisted radical prostatectomy. Nationwide, population-based study. J Surg Oncol. 2017 Sep;116(4):500-506. doi: 10.1002/jso.24687. Epub 2017 Jun 7. Tiruye T, O'Callaghan M, Moretti K, Jay A, Higgs B, Santoro K, Boyle T, Ettridge K, Beckmann K. Patient-reported functional outcome measures and treatment choice for prostate cancer. BMC Urol. 2022 Nov 5;22(1):169. doi: 10.1186/s12894-022-01117-1. Chandrasekar T, Tilki D. Prostate cancer: Comparing quality of life outcomes after prostate cancer treatment. Nat Rev Urol. 2017 Jul;14(7):396-397. doi: 10.1038/nrurol.2017.81. Epub 2017 Jun 13. No abstract available.
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Nathan Lawrentschuk, MBBS,PhD, FRACS
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Address
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Phone
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+6193291197
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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
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
* Patient data will only be transferred and analysed in a coded form by mentioned investigators.
* Transferring patient data will require host organisation's formal approval
* Individual patients will not be identifiable from the presented or published material.
* The institution and the researcher must comply with all relevant laws and standards in relation to the use of the material.
* The institution and researcher must not use the material for any purpose other than the specified research or other purposes expressly permitted under the terms of the Agreement.
* Data linkage across sites will be set up when necessary. Once linkage has been completed, identifiers will be removed from the data to be used in the research, unless consent has been given for its identifiable use.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06279260