Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001012965
Ethics application status
Approved
Date submitted
20/07/2020
Date registered
7/10/2020
Date last updated
29/03/2022
Date data sharing statement initially provided
7/10/2020
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
None
Universal Trial Number (UTN)
Trial acronym
MDS
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

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
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
Uncontrolled

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have chosen to ‘opt-out’ of the Registry.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/08/2018
Date of last participant enrolment
Anticipated
24/05/2023
Actual
Date of last data collection
Anticipated
24/05/2028
Actual
Sample size
Target
300
Accrual to date
123
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 306238 0
Commercial sector/Industry
Name [1] 306238 0
The Australian & New Zealand Society of Blood Transfusion (ANZSBT)
Country [1] 306238 0
Australia
Funding source category [2] 306255 0
Commercial sector/Industry
Name [2] 306255 0
Celgene
Country [2] 306255 0
Australia
Primary sponsor type
University
Name
Monash University
Address
553 St Kilda Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 306740 0
None
Name [1] 306740 0
Address [1] 306740 0
Country [1] 306740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306448 0
Monash Health HREC
Ethics committee address [1] 306448 0
Ethics committee country [1] 306448 0
Australia
Date submitted for ethics approval [1] 306448 0
17/04/2018
Approval date [1] 306448 0
24/05/2018
Ethics approval number [1] 306448 0
HREC/18/MonH/341

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.