NeoplasmsNCT05615376
Beat to Beat A Study in Paediatric, Adolescent and Young Adult Patients Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG
A study testing ECG application and 12 lead ECG in people with Neoplasms and Cardiac Arrhythmia, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to evaluate the agreement between QTc measured using 12 lead electrocardiogram (ECG) and the wearable device ECG. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Neoplasms, Cardiac Arrhythmia
- What is being tested?
- ECG application and 12 lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Feb 2023to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days at the time of consent.
- Patient age ≥ 7 years at time of eligibility screening
- If age < 18 years, parent or guardian able to provide consent
- Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:
- iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility.
- Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.
Show all 9Show fewer
- Valid phone number associated with iPhone, ascertained from self-report.
- Valid email address, ascertained from self-report.
- Participants or parents need to be able to press down on the wearable device crown for 30 seconds
Who cannot join
- Unable to wear the wearable device.
- < 18 years of age without guardian or parent to provide consent.
- Interpreter required for consent purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beat to Beat A Prospective Study in Paediatric, Adolescent and Young Adult Patients Aged 7 to 18 Years of Age Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG
A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to evaluate the agreement between QTc measured using 12 lead electrocardiogram (ECG) and the wearable device ECG.
Read the detailed description
Rationale: Leveraging existing wearable technology has the ability to scale routine screening strategies across large populations and can facilitate ambulatory care. In recent years, wearable technology has rapidly diffused into consumer markets and provides unique opportunities to engage individuals on health issues of personal interest, and to collect personal health data. One example of such technology is the ability to perform electrocardiogram (ECG) type traces on wearable devices. However, utilization of this data source to improve patient outcomes has not been fully realized in the health care field. An app-based heart ECG algorithm that can be remotely analysed for QTc prolongation with potential to then notify the user of such potential irregularities could lead to widespread screening, detection and initiation of treatment solutions (i.e. correction of electrolytes, alteration of exacerbating medications, cardiac monitoring etc).
Trial Design: This will be a prospective, single arm, experimental, non-significant risk study conducted with the assistance of eligible participants. Parents or mature minors will download the Beat to Beat app, once consented.
Once consented the wearable device will be paired to the parent/guardians phone following the steps provided by the wearable device app. Once the device is paired and the study coordinator has assisted with the download of 'Beat to Beat' app, the patients will then be able to commence the ECG readings. A 12 lead ECG will be performed by the study team and immediately following this, an ECG will be recorded on the wearable device. The wearable device will be placed on the left wrist for a Lead I reading, on the left lower abdomen for a Lead II reading and in the fourth intercostal space left parasternal for a chest V2 Lead reading. Recording of the 12 lead ECG and wearable device ECG will be repeated again 4 days later. Once both timepoints (and two device recordings for each time period) have been completed the ECGs will be retrieved from the Beat to Beat app. Both the 12 lead and wearable device ECG will be de-identified and given a patient identifier before being uploaded into the REDCap database.
- Conditions
- Neoplasms, Cardiac Arrhythmia
- Being tested
- ECG application, 12 lead ECG
- Keywords
- QT prolongation, cancer, paediatric, ECG application, 12 lead ECG
- Medical subject headings
- Neoplasms, Arrhythmias, Cardiac, Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG applicationDevice
The app together with the wearable device will record a V1 (Left wrist) or V2 (left ankle) ECG reading. These measurements will be conducted on Day 1 and Day 4.
12 lead ECGDevice
The 12 lead ECG will measure corrected QT interval by recording RR and QT intervals on Day 1 and Day 4. This will be performed within the same episode of care as the wearable device ECG recording. There is no need to perform both at exactly the same time point, but within a 15 minute window.
| Study group | Role | What they receive |
|---|---|---|
| ECG App arm | Experimental | Participants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital. Receives: Device: ECG application; Device: 12 lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of a 12 lead ECG and wearable device ECG
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Measured: Day 1 of inpatient stay
Recording of a 12 lead ECG and wearable device ECG
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Measured: Day 4 of inpatient stay
Calculation of QT interval by two blinded health professionals
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).
Measured: Day 1 of inpatient stay
Calculation of QT interval by two blinded health professionals
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).
Measured: Day 4 of inpatient stay
Secondary outcomes (8)
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
From the analysis of QT measurements from Outcome 2, prolonged or abnormal QTc measurement will be noted. An abnormal QTc is greater than 0.48mm. This data will be collected separately for each patient.
Measured: Day 1 inpatient stay
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
From the analysis of QT measurements from Outcome 2, prolonged or abnormal QTc measurement will be noted. An abnormal QTc is greater than 0.48mm. This data will be collected separately for each patient.
Measured: Day 4 inpatient stay
Sensitivity calculations of wearable device vs 12 Lead ECG
Sensitivity is calculated only in the participants who are declared to have QTc prolongation (abnormal QTc) and is calculated as the proportion patients with QTc prolongation on the wearable device among those with QTc prolongation on the 12-lead ECG.
Measured: Day 1 inpatient stay
Sensitivity calculations of wearable device vs 12 Lead ECG
Sensitivity is calculated only in the participants who are declared to have QTc prolongation (abnormal QTc) and is calculated as the proportion patients with QTc prolongation on the wearable device among those with QTc prolongation on the 12-lead ECG.
Measured: Day 4 inpatient stay
Specificity calculations of wearable device vs 12 Lead ECG
Specificity is calculated only in participants who do not have QTc prolongation and is calculated as the proportion patients who do not have QTc prolongation on the wearable device among those who do not have QTc prolongation on the 12-lead ECG.
Measured: Day 1 inpatient stay
Specificity calculations of wearable device vs 12 Lead ECG
Specificity is calculated only in participants who do not have QTc prolongation and is calculated as the proportion patients who do not have QTc prolongation on the wearable device among those who do not have QTc prolongation on the 12-lead ECG.
Measured: Day 4 inpatient stay
To calculate the interobserver variability between the two health care professional readings of QTc.
The corrected QT interval will be calculated on both the wearable device ECG and the 12 lead ECG for each patient and measured by a health professional. QT interval will be calculated by the health professional by using the QT and RR interval from the ECGs using Frederichia's interval (QTcF = QT divided by cube root of RR). This data will be collected separately for each patient. The standard deviation of the difference in QTc interval between the two observers will be reported.
Measured: Day 1 inpatient stay
To calculate the interobserver variability between the two health care professional readings of QTc.
The corrected QT interval will be calculated on both the wearable device ECG and the 12 lead ECG for each patient and measured by a health professional. QT interval will be calculated by the health professional by using the QT and RR interval from the ECGs using Frederichia's interval (QTcF = QT divided by cube root of RR). This data will be collected separately for each patient for each patient The standard deviation of the difference in QTc interval between the two observers will be reported.
Measured: Day 4 inpatient stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start7 Feb 2023
- Primary completion30 Jun 2024
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A/Prof Rachel Conyers, Principal investigator, The Royal Children's Hospital/Murdoch Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615376
- Sponsor's protocol ID
- 88476
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set collected for this analysis of the Beat to Beat trial will be available 12 months after publication of the primary outcome. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beat to Beat A Prospective Study in Paediatric, Adolescent and Young Adult Patients Aged 7 to 18 Years of Age Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG
- ClinicalTrials.gov ID
- NCT05615376
- Acronym / sponsor ID
- 88476
- Conditions
- Neoplasms, Cardiac Arrhythmia
- Keywords
- QT prolongation, cancer, paediatric, ECG application, 12 lead ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to evaluate the agreement between QTc measured using 12 lead electrocardiogram (ECG) and the wearable device ECG.
Detailed description
Rationale: Leveraging existing wearable technology has the ability to scale routine screening strategies across large populations and can facilitate ambulatory care. In recent years, wearable technology has rapidly diffused into consumer markets and provides unique opportunities to engage individuals on health issues of personal interest, and to collect personal health data. One example of such technology is the ability to perform electrocardiogram (ECG) type traces on wearable devices. However, utilization of this data source to improve patient outcomes has not been fully realized in the health care field. An app-based heart ECG algorithm that can be remotely analysed for QTc prolongation with potential to then notify the user of such potential irregularities could lead to widespread screening, detection and initiation of treatment solutions (i.e. correction of electrolytes, alteration of exacerbating medications, cardiac monitoring etc).
Trial Design: This will be a prospective, single arm, experimental, non-significant risk study conducted with the assistance of eligible participants. Parents or mature minors will download the Beat to Beat app, once consented.
Once consented the wearable device will be paired to the parent/guardians phone following the steps provided by the wearable device app. Once the device is paired and the study coordinator has assisted with the download of 'Beat to Beat' app, the patients will then be able to commence the ECG readings. A 12 lead ECG will be performed by the study team and immediately following this, an ECG will be recorded on the wearable device. The wearable device will be placed on the left wrist for a Lead I reading, on the left lower abdomen for a Lead II reading and in the fourth intercostal space left parasternal for a chest V2 Lead reading. Recording of the 12 lead ECG and wearable device ECG will be repeated again 4 days later. Once both timepoints (and two device recordings for each time period) have been completed the ECGs will be retrieved from the Beat to Beat app. Both the 12 lead and wearable device ECG will be de-identified and given a patient identifier before being uploaded into the REDCap database.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECG App arm | Experimental | Device: ECG application, Device: 12 lead ECGParticipants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days at the time of consent.
- Patient age ≥ 7 years at time of eligibility screening
- If age < 18 years, parent or guardian able to provide consent
- Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:
Key exclusion criteria (3 listed)
- Unable to wear the wearable device.
- < 18 years of age without guardian or parent to provide consent.
- Interpreter required for consent purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG applicationThe app together with the wearable device will record a V1 (Left wrist) or V2 (left ankle) ECG reading. These measurements will be conducted on Day 1 and Day 4. | Device | ECG App arm |
| 12 lead ECGThe 12 lead ECG will measure corrected QT interval by recording RR and QT intervals on Day 1 and Day 4. This will be performed within the same episode of care as the wearable device ECG recording. There is no need to perform both at exactly the same time point, but within a 15 minute window. | Device | ECG App arm |
Primary outcome
Recording of a 12 lead ECG and wearable device ECG
Time frame: Day 1 of inpatient stay
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Recording of a 12 lead ECG and wearable device ECG
Time frame: Day 4 of inpatient stay
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Calculation of QT interval by two blinded health professionals
Time frame: Day 1 of inpatient stay
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).
Calculation of QT interval by two blinded health professionals
Time frame: Day 4 of inpatient stay
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).
8 secondary outcomes
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Time frame: Day 1 inpatient stay
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Time frame: Day 4 inpatient stay
Sensitivity calculations of wearable device vs 12 Lead ECG
Time frame: Day 1 inpatient stay
Sensitivity calculations of wearable device vs 12 Lead ECG
Time frame: Day 4 inpatient stay
Specificity calculations of wearable device vs 12 Lead ECG
Time frame: Day 1 inpatient stay
Specificity calculations of wearable device vs 12 Lead ECG
Time frame: Day 4 inpatient stay
To calculate the interobserver variability between the two health care professional readings of QTc.
Time frame: Day 1 inpatient stay
To calculate the interobserver variability between the two health care professional readings of QTc.
Time frame: Day 4 inpatient stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of the Beat to Beat trial will be available 12 months after publication of the primary outcome. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.
Related trials for Neoplasms
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A/Prof Rachel Conyers principal investigator
The Royal Children's Hospital/Murdoch Children's Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG application and 12 lead ECG in people with Neoplasms and Cardiac Arrhythmia, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of a 12 lead ECG and wearable device ECG (time frame: Day 1 of inpatient stay). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.