Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000986471p
Ethics application status
Submitted, not yet approved
Date submitted
30/07/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Registry assessing heart outcomes in patients with cancer (CORIS-1)
Scientific title

A case-control registry assessing heart outcomes in patients with cancer and without cancer (C)RIS-1)
Secondary ID [1] 314706 0
None
Universal Trial Number (UTN)
Trial acronym
CORIS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 337893 0
cardiovascular disease risk 337894 0
Condition category
Condition code
Cancer 334224 334224 0 0
Bladder
Cancer 334225 334225 0 0
Prostate
Cancer 334678 334678 0 0
Testicular
Cancer 334679 334679 0 0
Breast
Cancer 334680 334680 0 0
Lung - Small cell
Cancer 334681 334681 0 0
Lung - Non small cell
Cancer 334682 334682 0 0
Lung - Mesothelioma
Cancer 334683 334683 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cardiovascular 334684 334684 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
24
Target follow-up type
Months
Description of intervention(s) / exposure
Patients' involvement is needed because this study is collecting data prospectively from medical record, treating teams, patients and CHeReL for linked data. In most case these data will be available from the treating team. If the data such as reaults of blood test, ECG or echocardiogram is not available, patients will be asked to do the tests.
Data to be colleted are medical history, cancer type and status, cancer treatment, vital signs, medication, ECG, echogardiogram, cardiovacular risk factors, blood tests, diet, questionnaires, cardiovascular events and cause of death.
Questionairres include short IPAQ, ECOG and PHQ-9 anticipated to take 15 minutes at enrollment, 12 months and 24 month.
The overall duration is 24 months from time of enrollement.
Intervention code [1] 331313 0
Not applicable
Comparator / control treatment
Controls will be recruited in parallel and consented to enter the study (at least one for each case) with the only inclusion criteria being that they do not have current or previous cancer at baseline.
Control group
Active

Outcomes
Primary outcome [1] 341884 0
the composite of cardiovascular death, myocardial infarction, stroke, heart failure, and arterial revascularisation
Timepoint [1] 341884 0
baseline, 12 months, 24months post enrollment
Secondary outcome [1] 448883 0
Presence of cardiovascular risk factors,
Timepoint [1] 448883 0
Baseline
Secondary outcome [2] 450786 0
all-cause mortality
Timepoint [2] 450786 0
12 months, 24 months post enrollement
Secondary outcome [3] 451278 0
overall survival
Timepoint [3] 451278 0
6 months, 12 months, 24 months post enrollment
Secondary outcome [4] 451281 0
cardiovascular medication adherence
Timepoint [4] 451281 0
6 months, 12 months, 24 months post enrollment
Secondary outcome [5] 451282 0
cardiovascular events
Timepoint [5] 451282 0
6 months, 12 months, 24 months post enrollment

Eligibility
Key inclusion criteria
Inclusion Criteria (cases):
1. Patients that are of 18 years of age and older.
2. The following oncological diagnoses
a. Prostate, bladder, testicular, lung, breast, and colorectal cancers
3. Receiving cancer therapy or have received cancer therapy within the last 5 years
4. Patients are willing to follow up at the enrolling center.

Inclusion Criteria (controls):
1. Participants that are of 18 years of age and older
2. No current or previous oncological diagnosis at baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient will not be following up at the participating site
2. Incapacity to provide written informed consent due to reasons other than language barriers

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2030
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319255 0
Government body
Name [1] 319255 0
NSW Health and Medical Research - NSW health Elite Grant
Country [1] 319255 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321729 0
None
Name [1] 321729 0
Address [1] 321729 0
Country [1] 321729 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317836 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317836 0
Ethics committee country [1] 317836 0
Australia
Date submitted for ethics approval [1] 317836 0
15/08/2025
Approval date [1] 317836 0
Ethics approval number [1] 317836 0

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

Contacts
Principal investigator
Name 142310 0
Dr Harry Klimis
Address 142310 0
Block K, level 5 Westmead Hospital Cnr Darcy and Hawkesbury Roads Westmead, NSW 2145
Country 142310 0
Australia
Phone 142310 0
+61 406997184
Fax 142310 0
Email 142310 0
[email protected]
Contact person for public queries
Name 142311 0
Kyunghee Park
Address 142311 0
Block K, level 5 Westmead Hospital Cnr Darcy and Hawkesbury Roads Westmead, NSW 2145
Country 142311 0
Australia
Phone 142311 0
+61 481068885
Fax 142311 0
Email 142311 0
[email protected]
Contact person for scientific queries
Name 142312 0
Harry Klimis
Address 142312 0
Block K, level 5 Westmead Hospital Cnr Darcy and Hawkesbury Roads Westmead, NSW 2145
Country 142312 0
Australia
Phone 142312 0
+61 406997184
Fax 142312 0
Email 142312 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

• statistitains at The Universy of Sydney

Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• participant's name, date of birth, sex and address when requesting data linkage for emergency/hospitalisation data and cause of death from CHeRel

What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 2 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: CHeReL : [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Instututional policy using secure data storage and consent for data linkage



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.