Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000962437p
Ethics application status
Not yet submitted
Date submitted
30/07/2025
Date registered
2/09/2025
Date last updated
2/09/2025
Date data sharing statement initially provided
2/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Stroke Thrombectomy Access in Cancer on Home Outcomes and decreased Morbidity: STAY-HOME-Cancer Phase II trial
Scientific title
Effectiveness of Stroke Thrombectomy Access in Cancer patient on Home Outcomes and Morbidity: STAY-HOME-Cancer Phase II trial
Secondary ID [1] 314805 0
Nil known
Universal Trial Number (UTN)
Trial acronym
STAY-HOME-Cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 338055 0
cancer 338484 0
Condition category
Condition code
Stroke 334349 334349 0 0
Ischaemic
Cancer 334788 334788 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will have clot extraction or aspiration catheter in the angiographic suite. This procedure may be performed under general anaesthesia. This decision is up to the interventional radiologists performing the procedure. The procedure may take 1 hour but can be longer for complex anatomy or clot. Following the procedure the interventional neuroradiologists will document the procedure in electronic medical record. Post-intervention: A non-contrast Computed Tomography (CT) and CT Angiography will be performed 24-to-48-hour post intervention. At the investigator’s discretion, a repeat CT Perfusion or Magnetic Resonance Imaging (MRI) may be performed at 24-to-48 hr.
Intervention code [1] 331402 0
Treatment: Devices
Comparator / control treatment
No control group. single arm phase II trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342035 0
degree of disability
Timepoint [1] 342035 0
1 month post baseline
Primary outcome [2] 342036 0
Commencement of cancer treatment
Timepoint [2] 342036 0
1 month poast baseline
Secondary outcome [1] 449381 0
degree of disability
Timepoint [1] 449381 0
3 month post baseline

Eligibility
Key inclusion criteria
1. Patients presenting with acute ischaemic stroke within 24 hours of stroke onset (in line with current criteria for thrombolysis).
2. National Institute of Health Stroke Scale (NIHSS)>4
3. Pre-stroke modified Rankin Score (mRS) score of 0-4
4. Patient’s age is 18 years and over (or as per local requirements)
5. Endovascular therapy (arterial puncture) within 90 minutes of initial CT brain.
6. Arterial occlusion on CT Angiography or MR Angiography (MRA) of large vessel occlusion (LVO)
7. Active cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients presenting with acute ischaemic stroke >24 hours of stroke onset.
2. Intracranial haemorrhage identified by CT or MRI.
3. Rapidly improving symptoms at the discretion of the investigator
4. Pre-stroke modified Rankin Score (mRS) score of 1/2 MCA or ACA territory on non-contrast CT.
6. Contraindication to imaging with contrast agents (requirement for performing thrombectomy)
7. Any condition that, in the judgment of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
8. Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 28263 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 28264 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 28265 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 28266 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 28267 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 28268 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 28302 0
Westmead Hospital - Westmead
Recruitment hospital [8] 28303 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 44475 0
3050 - Parkville
Recruitment postcode(s) [2] 44476 0
5000 - Adelaide
Recruitment postcode(s) [3] 44477 0
4215 - Southport
Recruitment postcode(s) [4] 44478 0
2305 - New Lambton
Recruitment postcode(s) [5] 44479 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 44480 0
2170 - Liverpool
Recruitment postcode(s) [7] 44514 0
2145 - Westmead
Recruitment postcode(s) [8] 44515 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 319358 0
Government body
Name [1] 319358 0
NHMRC
Country [1] 319358 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 322103 0
None
Name [1] 322103 0
Address [1] 322103 0
Country [1] 322103 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317936 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317936 0
Ethics committee country [1] 317936 0
Australia
Date submitted for ethics approval [1] 317936 0
30/09/2025
Approval date [1] 317936 0
Ethics approval number [1] 317936 0

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

Contacts
Principal investigator
Name 142618 0
Prof Thanh Phan
Address 142618 0
Monash Health, 246 Clayton Rd, Clayton, 3168 VICTORIA
Country 142618 0
Australia
Phone 142618 0
+61 385722612
Fax 142618 0
Email 142618 0
[email protected]
Contact person for public queries
Name 142619 0
Thanh Phan
Address 142619 0
Monash Health, 246 Clayton Rd, Clayton, 3168 VICTORIA
Country 142619 0
Australia
Phone 142619 0
+61 385722612
Fax 142619 0
Email 142619 0
[email protected]
Contact person for scientific queries
Name 142620 0
Thanh Phan
Address 142620 0
Monash Health, 246 Clayton Rd, Clayton, 3168 VICTORIA
Country 142620 0
Australia
Phone 142620 0
+61 385722612
Fax 142620 0
Email 142620 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.