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Trial registered on ANZCTR
Registration number
ACTRN12625000160437
Ethics application status
Approved
Date submitted
19/11/2024
Date registered
11/02/2025
Date last updated
11/05/2025
Date data sharing statement initially provided
11/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The Molecular Screening and Therapeutics in Leukaemia and Lymphoma Study in participants with haematological malignancies
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Scientific title
Evaluate the feasibility and benefits of the Molecular Screening and Therapeutics in Leukaemia and Lymphoma Study, in participants with haematological malignancies
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Secondary ID [1]
313423
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
MoST-LLy
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Linked study record
The study is based on the previous Haematology screening program MoST-LLy within the MoST framework protocol (ACTRN12616000908437), focusing on the previously established haematology screening program
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Health condition
Health condition(s) or problem(s) studied:
Myeloma
336479
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Leukaemia
336322
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Myelodysplastic syndrome (MDS)
336481
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Lymphoma
336478
0
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haematological malignancies
335793
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Myeloproliferative neoplasm (MPN)
336480
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Condition category
Condition code
Blood
332372
332372
0
0
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Haematological diseases
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Cancer
332370
332370
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
332367
332367
0
0
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Leukaemia - Acute leukaemia
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Cancer
332368
332368
0
0
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Leukaemia - Chronic leukaemia
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Cancer
332369
332369
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
332371
332371
0
0
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Myeloma
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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
This study will evaluate the feasibility and benefits of a molecular screening platform in participants with haematological malignancies (18 years or over). A national molecular tumour board will send a report to the referring haematologist with information on (i) Any genetic biomarkers that were identified in the blood cancer and (ii) The types of treatment that may be suitable (if any are found).
Eligible patients are invited to consent through the completion of a participant information and consent form (PICF). Participants consent to:
- a sample of their blood cancer sent for molecular screening.
- collection of medical and treatment history
- a short questionnaire (6 questions) to be completed after consent and at 6, 12 & 24months
- a research blood sample collected (can be done locally)
Consent, questionnaires and collection of blood sample may take up to 2 hours.
The national Molecular Tumour Board (MTB) of Haematologists, Genetics specialists and invited referring doctors review the results of the molecular screening via video conferencing on a regular basis (weekly/fortnightly as needed). Reports to referring haematologist are aimed to be sent between 6-8 weeks post consent.
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Intervention code [1]
329986
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Early Detection / Screening
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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]
339925
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Primary Outcome 3: Percentage of participants receiving treatment based on recommendation.
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Assessment method [1]
339925
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A review of medical records and follow up information received by referring clinician at 6, 12 and 24m
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Timepoint [1]
339925
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This will be monitored throughout the study at 6, 12 and 24 months post enrolment, with the final assessment at the end of the study.
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Primary outcome [2]
339924
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Primary Outcome 2: The percentage of participants receiving treatment recommendations on the basis of molecular screening.
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Assessment method [2]
339924
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Review of Haematology MTB reports.
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Timepoint [2]
339924
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This will be monitored throughout the study and assessed at the end of the enrolment period.
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Primary outcome [3]
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Primary Outcome 1: The percentage of participants with actionable molecular biomarkers identified in screened patients.
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Assessment method [3]
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Review of Haematology MTB reports.
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Timepoint [3]
339923
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This will be monitored throughout the study and assessed at the end of the enrolment period.
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Secondary outcome [1]
441941
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Secondary Outcome 1: The number of participants enrolled into screening over defined periods
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Assessment method [1]
441941
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A review of trial recruitment records.
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Timepoint [1]
441941
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This will be monitored throughout the study and assessed at the end of the enrolment period
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Secondary outcome [2]
441943
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Review of assay performance including sequencing failure rate, costs per genotype screened will be assessed as a composite outcome.
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Assessment method [2]
441943
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review of data received from the MoST-LLy screening platform.
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Timepoint [2]
441943
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This will be monitored throughout the study and assessed at the end of the enrolment period after all participants have Haem MTB reporting completed.
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Secondary outcome [3]
441946
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Secondary Outcome 6: Real-world progression-free survival (rwPFS) - time during which the patient lives without disease worsening or death
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Assessment method [3]
441946
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Medical records and follow up information received by referring clinician at 6, 12 and 24 months.
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Timepoint [3]
441946
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This will be monitored throughout the study at 6, 12 and 24 months post enrolment, with the final assessment at the end of the study.
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Secondary outcome [4]
441947
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Secondary Outcome 7: Overall Survival (OS) is defined as the interval from the date of consent to date of death from any cause. Participants who did not die will be censored at the date of last known follow-up alive
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Assessment method [4]
441947
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Medical records and follow up information received by referring clinician at 6, 12 and 24 months.
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Timepoint [4]
441947
0
This will be monitored throughout the study at 6, 12 and 24 months post enrolment, with the final assessment at the end of the study.
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Secondary outcome [5]
441944
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Descriptive list and frequency of all anti-cancer therapies received will be assessed as a composite outcome.
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Assessment method [5]
441944
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Medical records and follow up information received by referring clinician at 6, 12 and 24 months.
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Timepoint [5]
441944
0
This will be monitored throughout the study at 6, 12 and 24 months post enrolment, with the final assessment at the end of the study.
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Secondary outcome [6]
441945
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Secondary Outcome 5: Real-world best overall response (rwBOR): defined as as the percentage of participants with a complete response or partial response assessed by the investigator based on evaluable response assessments performed
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Assessment method [6]
441945
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Medical records and follow up information received by referring clinician at 6, 12 and 24 months.
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Timepoint [6]
441945
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Medical records and follow up information received by referring clinician at 6, 12 and 24 months.
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Secondary outcome [7]
441942
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Secondary Outcome 2: Time taken for molecular screening results to be made available, defined as: the interval from the date of consent to date of MTB report returned to clinician.
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Assessment method [7]
441942
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Review of trial recruitment records and MTB reports.
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Timepoint [7]
441942
0
This will be monitored throughout the study and assessed at the end of the enrolment period.
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Eligibility
Key inclusion criteria
1. Participants, aged 18 years and older, with pathologically confirmed blood cancer at initial diagnosis or relapse/refractory disease.
2. Sufficient and accessible tissue for molecular screening.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
4. Willing and potentially able to comply with study requirements.
5. Signed, written informed consent to participation in the molecular screening.
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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
1. Comorbidities or conditions which may contraindicate participation, compromise assessment of key outcomes or limit ability to comply with protocol.
2. Patient is eligible for Medicare Benefits scheme (MBS) funded Next Generation Sequencing (NGS), except where there is a clinical rationale to provide a larger sequencing panel or repeat sequencing.
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Study design
Purpose
Screening
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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
This is a descriptive study of 300 participants with haematological malignancies (Australia only), to screen and identify actionable genomic alterations with potential treatment options. With 300 participants the width of a 95% confidence interval for a proportion is approximately 0.11 if the proportion is around 0.6. This is a descriptive pilot study without any group comparisons and hypothesis tests.
The descriptive analysis will describe the feasibility, efficiency, and utility of implementation of molecular screening.
Tables will report the number of participants satisfying the various conditions of interest. All the key outcome percentages will be reported with 95% confidence intervals (computed using the Wilson Score method). Durations will be reported as median, range, 25th / 75th percentiles and mean (with standard deviation if approximately normal). Time to event outcomes will be summarised using Kaplan-Meier plots. Results will also be reported stratified by Lymphoma vs Leukaemia, genetic subgroup as well as by treatment pathway received.
The prognostic and potentially predictive value of genomic biomarkers will be examined in the entire cohort, as well as in lymphoma and leukaemia subgroups. Survival and efficacy endpoints associated with therapy linked to genomic profiling will be estimated using both response endpoints and time-to-event analyses.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
26/03/2025
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Actual
2/04/2025
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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
300
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
317854
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Charities/Societies/Foundations
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Name [1]
317854
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Luekaemia Foundation of Australia
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Address [1]
317854
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Country [1]
317854
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Australia
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Funding source category [2]
317853
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Government body
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Name [2]
317853
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Department of Health and AgedCare: Medical Research Future Fund (MRFF)
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Address [2]
317853
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Country [2]
317853
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Australia
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Primary sponsor type
Other
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Name
QIMRBerghofer Medical Research Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
320186
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None
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Name [1]
320186
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Address [1]
320186
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Country [1]
320186
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316535
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
316535
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https://metrosouth.health.qld.gov.au/research/about-us/hrec
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Ethics committee country [1]
316535
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Australia
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Date submitted for ethics approval [1]
316535
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14/11/2024
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Approval date [1]
316535
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21/01/2025
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Ethics approval number [1]
316535
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HREC/2024/QMS/113451
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Summary
Brief summary
This study aims to evaluate the feasibility and benefits of molecular screening in participants with haematological malignancies. Who is it for? You may be eligible for this study if you are: - aged 18 years and older - have pathologically confirmed blood cancer at diagnosis or relapsed/refractory disease - have sufficient and accessible tissue for molecular screening - ECOG performance status 0, 1 or 2. Study details If a patient is suitable for the MoST-LLy study, their blood cancer is tested for genetic biomarkers that may guide future treatment/s. This process is called molecular screening or genetic panel testing. After a patient’s blood cancer is tested, a report is sent to the referring haematologist with information on (i) Any genetic biomarkers that were identified in the blood cancer and (ii) The types of treatment/s or clinical trials/s that may be suitable (if any are found). The intervention and results of the screening will be assessed for biomarker identification, treatment recommendations, patient and treatment metrics and clinical outcomes. It is hoped that this research project will contribute to a better understanding of blood cancers and blood cancer genomics that may help people with blood cancer in the future. The results will aim to show genetic screening is important to expedite translation of discovery into treatment options and ultimately better outcomes for blood cancer patients.
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Trial website
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Trial related presentations / publications
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Public notes
MoST-LLy is currently established as a haematology cohort under the Molecular Screening and Therapeutics (MoST) program (ACTRN12616000908437). With the MoST program due to close at the end 2024, there is still unmet need within the blood cancer population to provide access to biomarker identified novel therapeutic opportunities. Remaining funding from LFA and the MoST-LLy MRFF Grant supports this protocol to provide molecular screening and the opportunity for new treatments and new indications. This registration record is describing the molecular screening stage only of the MoST-LLy protocol and is observational in nature as this screening process is conducted before any interventional treatment/care is determined for participants.
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Contacts
Principal investigator
Name
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Prof Steven Lane
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Address
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QIMR Berghofer Medical Research Institute Locked Bag 2000 Royal Brisbane Hospital, QLD 4029
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Country
138194
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Australia
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Phone
138194
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+61 7 3845 3766
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Fax
138194
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Email
138194
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[email protected]
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Contact person for public queries
Name
138195
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MoST-LLy project manager
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Address
138195
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QIMR Berghofer Medical Research Institute Locked Bag 2000 Royal Brisbane Hospital, QLD 4029
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Country
138195
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Australia
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Phone
138195
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+61738453678
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Fax
138195
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Email
138195
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[email protected]
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Contact person for scientific queries
Name
138196
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Prof Steven Lane
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Address
138196
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QIMR Berghofer Medical Research Institute Locked Bag 2000 Royal Brisbane Hospital, QLD 4029
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Country
138196
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Australia
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Phone
138196
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+61733620222
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Fax
138196
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Email
138196
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Currently no plan and participant consent will be required
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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