Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000427471
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
8/05/2025
Date last updated
29/06/2025
Date data sharing statement initially provided
8/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Motor Neuron Disease Surveillance Unit in New South Wales
Scientific title
A prospective observational surveillance study to monitor motor neuron disease in New South Wales
Secondary ID [1] 314268 0
Nil known
Universal Trial Number (UTN)
MND-SU-NSW
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor Neuron Disease 337206 0
Condition category
Condition code
Neurological 333616 333616 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an observational study with no treatment intervention.
Recruitment over a 3 -year period starting from July 2025 to July 2027. Invitation to participate is through the participants' general practitioner (GP). A 30-45 min telehealth appointment between the participant, their GP and a neurologist will be set up as a one-off consultation. Participants will be asked to describe any MND symptoms, family history of MND or dementia and treatments received for these symptoms. This 3-way telehealth appointment (participant, GP, neurologist) can be arranged by the GP via a website and secure online portal (REDCap). Participants identified to probably have MND by the neurologist at the telehealth consultation will be invited to attend the MND clinic for further physical examination and tests together with routine care for MND patients.
This is an epidemiology study to identify MND incident cases, therefore assessments and tests are not included in the design of the study.
Intervention code [1] 330882 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341193 0
Identify new MND incident cases in NSW
Timepoint [1] 341193 0
At time of entry into the study
Secondary outcome [1] 447038 0
MND point prevalence at the end of 3 years
Timepoint [1] 447038 0
At time of entry to the study

Eligibility
Key inclusion criteria
• Patients must be residents in NSW
• Patients identified by their primary healthcare professional with MND red flags
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27804 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 43998 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 318789 0
Government body
Name [1] 318789 0
NSW Health
Country [1] 318789 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 321230 0
None
Name [1] 321230 0
Address [1] 321230 0
Country [1] 321230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317397 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317397 0
Ethics committee country [1] 317397 0
Australia
Date submitted for ethics approval [1] 317397 0
14/04/2025
Approval date [1] 317397 0
24/06/2025
Ethics approval number [1] 317397 0
Reference No: 520251916263352 (Project ID: 19162)

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

Contacts
Principal investigator
Name 140930 0
Prof Dominic Rowe
Address 140930 0
Suite 204/2 Technology Place Macquarie University, NSW 2109, Australia
Country 140930 0
Australia
Phone 140930 0
+61 2 9812 3720
Fax 140930 0
Email 140930 0
[email protected]
Contact person for public queries
Name 140931 0
Carol Lee
Address 140931 0
Suite 204/2 Technology Place Macquarie University, NSW 2109, Australia
Country 140931 0
Australia
Phone 140931 0
+61 2 9812 3738
Fax 140931 0
Email 140931 0
[email protected]
Contact person for scientific queries
Name 140932 0
Dominic Rowe
Address 140932 0
Suite 204/2 Technology Place Macquarie University, NSW 2109, Australia
Country 140932 0
Australia
Phone 140932 0
+61 2 9812 3720
Fax 140932 0
Email 140932 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Available upon request
Informed consent form  [email protected] Available upon request
Ethical approval  [email protected] Available upon request


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.