Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002015224
Ethics application status
Approved
Date submitted
27/11/2018
Date registered
17/12/2018
Date last updated
21/06/2021
Date data sharing statement initially provided
17/12/2018
Date results provided
21/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of serum cardiac biomarkers and left ventricular strain imaging for detecting early radiation induced myocardial damage
Scientific title
The role of serum cardiac biomarkers and left ventricular strain imaging for detecting early radiation induced myocardial damage
Secondary ID [1] 296720 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Left ventricular dysfunction 310583 0
Breast Cancer 310584 0
Radiation Therapy 310585 0
Condition category
Condition code
Cardiovascular 309296 309296 0 0
Other cardiovascular diseases
Cancer 309297 309297 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will have an ECG performed prior to commencing radiation therapy and at the end of their treatment course. Patients will undergo blood sampling at Day 1 to Day 5 of the first week of radiation therapy which will be performed on arrival for their treatment. Following the first week blood will be sampled only on Day 1 of the subsequent weeks for the duration of the treatment schedule. Patients will also undergo cardiac ultrasound with transthoracic echocardiography with a machine capable of calculating strain rates on the images obtained. This will be performed prior to commencing radiation therapy, immediately after finishing the 6-week course of radiation therapy and at least 12-months after treatment and will be assessed by a cardiologist for reduction in left ventricular function.

Intervention code [1] 313028 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308264 0
To measure the change in serum high-sensitivity troponin and NT-pro BNP levels in patients during radiation therapy
Timepoint [1] 308264 0
Serum testing at enrolment and at the end of radiation therapy (6 weeks)
Secondary outcome [1] 354462 0
To measure the change in left ventricular strain rate in patients undergoing radiation therapy using global longitudinal strain and strain rate on transthoracic echocardiography.
Timepoint [1] 354462 0
6 weeks post-enrolment (end of radiation therapy)

Eligibility
Key inclusion criteria
All women over the age of 18 years with left sided breast cancer undergoing radiation therapy at the Olivia Newton John Cancer and Wellness Centre
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are receiving adjuvant chemotherapy or Herceptin. Patients who are unable to provide informed consent will be excluded. Additionally, patients who withdraw their consent at any stage will be excluded from the rest of the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Normalised data will be expressed as mean ± standard deviation. Continuous data will be evaluated by Student’s t-test or Mann-Whitney U test as appropriate. Categorical data will be expressed as n (%) and analyzed using Fisher’s exact test. Differences in paired samples will be evaluated by Wilcoxon signed-rank test. Two-tailed p-values <0.05 will be considered significant. A sample size calculation has not been performed for this preliminary investigation, as it is a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/02/2018
Date of last participant enrolment
Anticipated
24/12/2018
Actual
4/02/2019
Date of last data collection
Anticipated
3/02/2020
Actual
3/02/2020
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12566 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 24945 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301300 0
Charities/Societies/Foundations
Name [1] 301300 0
Austin Health Medical Research Foundation
Country [1] 301300 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Austin Health Medical Research Foundation
Address
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country
Australia
Secondary sponsor category [1] 300953 0
None
Name [1] 300953 0
N/A
Address [1] 300953 0
N/A
Country [1] 300953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302043 0
AUSTIN HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 302043 0
Ethics committee country [1] 302043 0
Australia
Date submitted for ethics approval [1] 302043 0
20/11/2017
Approval date [1] 302043 0
12/12/2017
Ethics approval number [1] 302043 0
HREC/17/Austin/533

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

Contacts
Principal investigator
Name 88934 0
Dr Terase Lancefield
Address 88934 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country 88934 0
Australia
Phone 88934 0
+61 3 94565000
Fax 88934 0
Email 88934 0
[email protected]
Contact person for public queries
Name 88935 0
Alexandra Murphy
Address 88935 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country 88935 0
Australia
Phone 88935 0
+61 3 94965000
Fax 88935 0
Email 88935 0
[email protected]
Contact person for scientific queries
Name 88936 0
Alexandra Murphy
Address 88936 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country 88936 0
Australia
Phone 88936 0
+61 3 94965000
Fax 88936 0
Email 88936 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
Data collected will be used in this study only.


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.