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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000401156
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
12/03/2019
Date last updated
25/04/2024
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
MINERAL: Magnetic Resonance Imaging and Quantitative Susceptibility Mapping (MRI-QSM) of brain iron to identify Chemotherapy-Associated Neurocognitive Impairment (CANI) in Acute Myeloid Leukaemia (AML).
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Scientific title
MINERAL: Magnetic Resonance Imaging and Quantitative Susceptibility Mapping (MRI-QSM) of brain iron to identify Chemotherapy-Associated Neurocognitive Impairment (CANI) in Acute Myeloid Leukaemia (AML).
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Secondary ID [1]
297617
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CT-2018-CTN-03575-1
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Universal Trial Number (UTN)
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Trial acronym
MINERAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia
311890
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Condition category
Condition code
Cancer
310478
310478
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0
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Leukaemia - Acute leukaemia
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Intervention/exposure
Study type
Observational
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Patient registry
False
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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
Prospective observational longitudinal cohort study (pilot study).
Patients undergoing standard chemotherapy treatment will be eligible for participation in this study.
In addition to their standard management, participants will undergo observations at three time points to identify any potential signs of chemotherapy-associated neurocognitive impairment (CANI).
These observations include:
- Neurocognitive Assessment (NCA), in the form of a one-hour standardised interview with a clinical neuropsychologist (see below); and
- Magnetic resonance imaging with quantitative susceptibility mapping (MRI-QSM) brain imaging.
The observations will be performed at baseline, at completion of chemotherapy, and then again at 6 months following completion of all therapy.
The 1-hour standardised NCA will contain the following validated assessment tools:
1) Test of Premorbid Function (TOPF), which will provide an overall estimate of the participant’s overall intelligence level. Number of years of education will be documented.
2) Mini Mental State Examination (MMSE) will provide an indication of global cognitive functioning.
3) Cognition will be assessed using measures to evaluate motor speed (the Finger Tapping Test), auditory attention and working memory (Wechsler Memory Scale – Third Edition Digit Span), verbal learning and memory (Rey Auditory Verbal Learning Test) and aspects of executive functioning including mental flexibility (Trail Making Test) and verbal generativity (Controlled Oral Word Association Test (COWAT).
4) Psychological variables will be evaluated through self-report questionnaires canvasing anxiety and depression (Hospital Anxiety and Depression Scale), patient perception of quality of life – European Organisation for Research and Treatment of Cancer Quality of Life Scale (EORTC-QLQ-C30) and evaluation of subjective symptoms of fatigue (EORTC-QLQ-FA12).
An overall composite score will be tallied for the NCA at each Time Point.
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Intervention code [1]
313855
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Not applicable
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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]
319343
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Change in composite NCA Score between baseline and following completion of consolidation chemotherapy (based on one-hour interview with clinical neuropsychologist using methods detailed in Step 3)
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Assessment method [1]
319343
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Timepoint [1]
319343
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The primary outcome will be assessed following the completion of the final time point by the final study participant (ie when all study data has been collected).
It is expected that each participant will have completed all study assessments within 9-12 months.
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Secondary outcome [1]
367845
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1., Change in NCA Score between completion of consolidation chemotherapy and six-month follow-up (based on one-hour interview with clinical neuropsychologist using methods detailed in Step 3)
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Assessment method [1]
367845
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Timepoint [1]
367845
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All outcomes will be after the assessed following the completion of the final time point (6 months post final treatment) for all participants.
It is expected that each participant will have completed all study assessments within 9-12 months.
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Secondary outcome [2]
367925
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2. Worst score in any NCA target area between baseline, completion of consolidation chemotherapy, and six-month follow-up.
(target areas detailed in Step 3; assessment performed based on one-hour interview with clinical neuropsychologist using methods detailed in Step 3)
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Assessment method [2]
367925
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Timepoint [2]
367925
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All outcomes will be after the assessed following the completion of the final time point (6 months post final treatment) for all participants.
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Secondary outcome [3]
367926
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3. Change in brain iron deposition pattern on MRI-QSM imaging between baseline, post consolidation chemotherapy, and six months’ follow-up
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Assessment method [3]
367926
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Timepoint [3]
367926
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All outcomes will be after the assessed following the completion of the final time point (6 months post final treatment) for all participants.
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Eligibility
Key inclusion criteria
Adults commencing induction chemotherapy for Acute Myeloid Leukaemia (AML).
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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
Medical contraindications to MRI according to institutional policy;
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Patient and treatment characteristics and study outcomes will be described using mean, standard deviation and range or median, interquartile range and range for continuous variables, frequencies and percentages for categorical variables and the Kaplan-Meier method for time-to event variables. A mixed effect model will be used.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
13/03/2019
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Actual
22/03/2019
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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
24
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Accrual to date
21
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
13314
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
25904
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
302160
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Charities/Societies/Foundations
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Name [1]
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Royal Brisbane and Women's Hospital Foundation
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Address [1]
302160
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James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston QLD 4029
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Country [1]
302160
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Australia
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Primary sponsor type
Hospital
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Name
Metro North Hospital and Health Service
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Address
c/o Dr Ashleigh Scott
Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston QLD 4029
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Country
Australia
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Secondary sponsor category [1]
301997
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None
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Name [1]
301997
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Address [1]
301997
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Country [1]
301997
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302841
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Royal Brisbane and Women's Hospital EC00172
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Ethics committee address [1]
302841
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Butterfield St, Herston QLD 4029
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Ethics committee country [1]
302841
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Australia
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Date submitted for ethics approval [1]
302841
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21/09/2018
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Approval date [1]
302841
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16/11/2018
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Ethics approval number [1]
302841
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HREC/2018/QRBW/45522
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Summary
Brief summary
This study seeks to detect chemotherapy-associated neurocognitive impairment in patients with Acute Myeloid Leukemia, using Neurocogntive Assessment and Magnetic Resonance Imaging.
Who is it for?
You may be eligible to join this study if you are aged 18 and above and are commencing induction chemotherapy for Acute Myeloid Leukaemia (AML).
Study details
This prospective longitudinal pilot study seeks to determine the prevalence and severity of chemotherapy-associated neurocognitive impairment (CANI) in patients undergoing treatment for AML, and to evaluate the feasibility of using magnetic resonance imaging as a biomarker of CANI in this population. Each participant will undergo Neurocognitive Assessment (NCA) and Magnetic Resonance Imaging Quantitative Susceptibility Mapping of brain iron (MRI-QSM) before and after their treatment for AML
It is hoped that the findings from this trial will provide information regarding the incidence of chemotherapy associated neurocognitive impairment during AML treatment, and the feasibility of using MRI-QSM as a diagnostic tool in these 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
91574
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Dr Ashleigh Scott
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Address
91574
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Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
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Country
91574
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Australia
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Phone
91574
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+61736468111
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Fax
91574
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Email
91574
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[email protected]
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Contact person for public queries
Name
91575
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Dr Ashleigh Scott
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Address
91575
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Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
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Country
91575
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Australia
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Phone
91575
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+61736468111
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Fax
91575
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Email
91575
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[email protected]
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Contact person for scientific queries
Name
91576
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Dr Ashleigh Scott
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Address
91576
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Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
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Country
91576
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Australia
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Phone
91576
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+61736468111
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Fax
91576
0
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Email
91576
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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
as per ethics approval
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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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