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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Myelodysplastic Syndromes (MDS) Patient Registry
Scientific title
Australian Myelodysplastic Syndromes (MDS) Patient Registry
Secondary ID [1] 301808 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes
318284 0
Condition category
Condition code
Cancer 316299 316299 0 0
Other cancer types
Blood 316635 316635 0 0
Haematological diseases

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This patient registry is using the registry as a framework to collect data on patient demographics including family history, relevant clinical results, treatment history, participant and survival status.
The data is obtained from participating hospitals accessing the medical records by hospital staff/ authorised staff.
Patients are asked to complete the EORTC QLQ-C30 and QUALMS questionnaire as part of their follow up appointments whilst being at the hospital or can be send out via email, if that is an option for the patient. This is anticipated to take about 15-20 minutes. The questionnaires occur 6 monthly up to 3 years. Depending on the set up patients can complete the questionnaire via email link at home in their own time and by submitting this information is directly captured in an electronic case report form (CRF). If the patient is at the hospital, the questionnaires will be provided and to be completed after the appointment. A nurse or trained staff will assist to answer questions, if necessary, check for completeness and will collect the questionnaires to enter into the database.
Intervention code [1] 318104 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group

Primary outcome [1] 324464 0
Overall survival which is assessed by review of hospital records.
Timepoint [1] 324464 0
For surviving patients, overall survival will be censored on the date the patient was last known to be alive as assessed at 5 years post-enrolment
Secondary outcome [1] 384746 0
duration of response to next treatment, which is assessed by review of hospital records.
Timepoint [1] 384746 0
6 monthly reviews up to 3 years
Secondary outcome [2] 384766 0
The EORTC QLQ-C30 is a measure of health-related quality of life in cancer patients and is collected at the same time then the QUALMS (Quality of Life in Myelodysplasia Scale) questionnaire.
Timepoint [2] 384766 0
6 monthly up to 3 years
Secondary outcome [3] 386822 0
The QUALMS (Quality of Life in Myelodysplasia Scale) questionnaire is a patient-reported outcome survey with a specific MDS focus in the modern treatment era, with a more specific focus on MDS.
Timepoint [3] 386822 0
6 monthly up to 3 years

Key inclusion criteria
Patients with a new diagnosis of MDS confirmed on bone marrow biopsy.
• This will include new diagnosis within 12 months prior to HREC approval at the site.
• Or, cause of death listed as MDS within 12 months prior to HREC approval at the site.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients who have chosen to ‘opt-out’ of the Registry.

Study design
Natural history
Defined population
Statistical methods / analysis
Analysis plans will be reviewed by the Steering Committee and by a suitably qualified statistician prior to data from the MDS being analysed.
A detailed pre-determined statistical plan will be developed prior to planned analyses of registry data.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 306238 0
Commercial sector/Industry
Name [1] 306238 0
The Australian & New Zealand Society of Blood Transfusion (ANZSBT)
Address [1] 306238 0
145 Macquarie Street,
Sydney NSW 2000, Australia
Country [1] 306238 0
Funding source category [2] 306255 0
Commercial sector/Industry
Name [2] 306255 0
Address [2] 306255 0
15/60 City Rd, Southbank VIC 3006
Country [2] 306255 0
Primary sponsor type
Monash University
553 St Kilda Rd
Melbourne VIC 3004
Secondary sponsor category [1] 306740 0
Name [1] 306740 0
Address [1] 306740 0
Country [1] 306740 0

Ethics approval
Ethics application status
Ethics committee name [1] 306448 0
Monash Health HREC
Ethics committee address [1] 306448 0
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Ethics committee country [1] 306448 0
Date submitted for ethics approval [1] 306448 0
Approval date [1] 306448 0
Ethics approval number [1] 306448 0

Brief summary
The primary purpose of this study is to provide long-term patient follow-up, and review of clinical and correlative data outside of clinical trials.

Who is it for?
The registry will collect information on patients age 18 years or older, with a new diagnosis of Myelodysplastic syndrome (MDS).

Study details
Treating clinicians at sites will identify patients at the time of referral and enrol them to the study. The following categories of data items will be collected to the Myelodysplastic syndrome database using a web portal:
• Health at diagnosis
• Demographic details
• Laboratory and bone marrow biopsy results at diagnosis including cytogenetics and
molecular studies if available
• Therapy decisions including pharmacological agents, transfusion practice and supportive
therapy, and side effects of treatment
• Outcomes (overall and progression free survival, duration of response and time to next
treatment and quality of life measures – EORTC QLQ-C30, QUALMS)
• Long-term outcomes (through linkage with Cancer and Death Registries)
Patients are asked to completed both questionnaires 6 monthly up to 3 years either at their hospital appointment or send to them via email.

It is hoped that the data collected for this registry will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies for Myelodysplastic syndrome and will assist with monitoring patient access to care, as well as monitoring trends in Myelodysplastic syndrome incidence and survival in Australia.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 103914 0
A/Prof Melita Kenealy
Address 103914 0
Cabrini Health Australia
243 New Street
Brighton VIC 3186
Country 103914 0
Phone 103914 0
+61 3 9500 9345
Fax 103914 0
Email 103914 0
Contact person for public queries
Name 103915 0
A/Prof Melita Kenealy
Address 103915 0
Cabrini Health Australia
243 New Street
Brighton VIC 3186
Country 103915 0
Phone 103915 0
+61 3 9500 9345
Fax 103915 0
Email 103915 0
Contact person for scientific queries
Name 103916 0
A/Prof Melita Kenealy
Address 103916 0
Cabrini Health Australia
243 New Street
Brighton VIC 3186
Country 103916 0
Phone 103916 0
+61 3 9500 9345
Fax 103916 0
Email 103916 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results