Breast CancerQT-RIBRATINGNCT05623397
A Deep Learning Method to Evaluate QT on Ribociclib
An observational study of Breast Cancer and Ribociclib, run by CMC Ambroise Paré at 4 sites in France.
Trial summary
"Deep-learning" is a fast-growing method of machine learning (artificial intelligence, AI) which is arousing the interest of the scientific committee in many medical fields. These methods make it possible to generate matches between raw inputs (such as the digital signal from the ECG) and the desired outputs (for… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ribociclib
- What is being tested?
- Acquisition of a digitized ECG by four modalities within 20 minutes
- How many people
- 70 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Jul 2023to 8 Oct 2025
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients requiring ribociclib for their standard of care at the clinically indicated dose, as per treating physician. Association with other hormone-derived therapeutics will be allowed.
Who may be able to join
- Adult female patients requiring start of ribociclib based therapy for a breast cancer in their standard of care, as per their summary of product characteristic's indications
- Association with hormone-based therapy in combination is authorized (aromatase inhibitors or fulvestrant)
- Able to provide an informed consent
Who cannot join
- Any allergy or contra-indication to ribociclib as mentioned in their as summary of product characteristic's
- Patients presenting a condition precluding accurate QTc measurements on electrocardiogram, i.e paced ventricular rhythm, multiples premature ventricular or supra-ventricular contractions, ventricular tachycardia, supraventricular arrhythmia (including atrial fibrillation, flutter or junctional rhythm)
- Patients with an atrial pacing and sinus dysfunction
- Patients presenting a contra-indication for ECG measurement, or with a device rendering ECG measurements impossible (i.e. Diaphragmatic pacing)
- Patients presenting a contra-indication to ribociclib start; including association with prohibited drug potentializing the risk of TdP
Trial locations and contacts
4 sites in 1 country.
France4 sites
Groupe Ambroise Paré, Hartmann
Neuilly-sur-Seine, 92200
Hôpital Tenon
Paris, 75020
CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE
Paris, 75651
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: QT on RIBociclib measuRed by ArTificial INteliGence
"Deep-learning" is a fast-growing method of machine learning (artificial intelligence, AI) which is arousing the interest of the scientific committee in many medical fields. These methods make it possible to generate matches between raw inputs (such as the digital signal from the ECG) and the desired outputs (for example, the measurement of QTc). Unlike traditional machine learning methods, which require manual extraction of structured and predefined data from raw input, deep-learning methods learn these functionalities directly from raw data, without pre-defined guidelines. With the advent of big-data and the recent exponential increase in computing power, these methods can produce models with exceptional performance. The investigators recently used this type of method using multi-layered artificial neural networks, to create an application based on a model that directly transforms the raw digital data of ECGs (.xml) into a measure of QTc comparable to those respecting the highest standards concerning reproducibility.
The main purpose of this trial is to study the performance of our DL-AI model for QTc measurement (vs. best standards of QTc measurements, TCM) applied to the recommended ECG monitoring following ribociclib prescription for breast cancer patients in routine clinical care. The investigators will acquire ECG with diverse devices including simplified devices (one/three lead acquisition, low frequency sampling rate: 125-500 Htz) to determine if they'll be equally performant versus 12-lead acquisition machine to evaluate QTc in this setting.
- Conditions
- Breast Cancer, Ribociclib
- Being tested
- Acquisition of a digitized ECG by four modalities within 20 minutes
- Keywords
- Deep Learning, Ribociclib, QTc values
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition of a digitized ECG by four modalities within 20 minutesOther
Patients will have three visits during the cycle for a given dose (600mg/day, 400mg/day or 200mg/day): Baseline , Day 14, Day 28
At each visit, the patient will have the acquisition of a digitized ECG by four modalities within 20 minutes (A 10 second triplicate ECG with WELCH-ALYN ELI-280® with the three 10 sec ECGs collected at approximatively 2-minute intervals, 3 min holter acquisition with a CGM HI-patch ®, a 3 minutes acquisition with AliveCore 6L® device and 10 seconds triplicate acquisition with QT-medical ® device collected at approximatively 2-minute intervals ).
Concomitantly with the ECG acquisition, patients will have blood sampling for measurements of variables clinically important for assessment of QTc including potassium, fasting blood glucose, calcemia, magnesium, estradiol, progesterone, FSH, LH, D4-androstenedione, total and free testosterone, SHBG and TSH. Blood concentration of ribociclib will be also assessed.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients administered ribociclib. | Prospective cohort of consecutive breast cancer patients requiring ribociclib for their standard of care at the clinically indicated dose, as per treating physician prescription (600mg to 200mg/day for 21 days per 28 days cycle). Association with other hormone-derived therapeutics will be allowed. Receives: Other: Acquisition of a digitized ECG by four modalities within 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the values of QTc generated by method 1 (overlap method on triplicate of 10 seconds ECG concatenated, TCM; the method of reference) versus method 2 relying on AI methodology in patients' candidate for ribociclib start
Comparison of the 2 methods (TCM vs. DL-AI) to demonstrate if there is a clinically relevant mean QTc difference ≥ 5msec between the 2 methods.
Measured: One visit the day of ribociclib start (before ribociclib intake)
Secondary outcomes (4)
Compare the values of QTc generated by method 1 (overlap method after triplicate concatenation, TCM) versus method 2 (DL-AI) in patients' on/off ribociclib using a digitized 12-lead acquisition ECG device
Bland-Altman plots and intra-class correlation will be generated to compare QTc values obtained by TCM vs. DL-AI on ribociclib (Day 14+/-3 days after start) and off-ribociclib (Day 28 +/-3 of ribociclib cycles).
Measured: One visit at day 14+/-3 and day 28+/-3 after start of ribociclib
Compare the values of QTc generated using method 2 (DL-AI) in patients' on/off ribociclib using a miniaturized and/or simplified ECG acquisition device (QT-Medical®, AliveCor®, a holter system (CGM HI-patch) versus using a digitized 12-lead acquisition
Compare QTc values obtained by DL-AI on/off ribociclib using a standard digitized 12-lead acquisition device (WELCH-ALYN ELI-280) versus each of three other miniaturized and/or simplified ECG acquisition devices (QT- Medical®, AliveCor®, CGM HI-patch®).
Measured: One visit at baseline before ribociclib start and then day 14+/-3 and day 28+/-3 after ribociclib start
The clinico-demographic predictors of amplitude of QTc prolongation on ribociclib.
Nonlinear mixed models will be used to study clinico-demographic determinants associated with magnitude of QTc prolongation on ribociclib.
Measured: One visit at baseline before ribociclib start and then day 14+/-3 and day 28+/-3 after ribociclib start
Learn ECG features at baseline using deep-learning predictors of magnitude of QTc prolongation on ribociclib
Using deep-learning seeking for a model using ECG raw data at baseline to predict magnitude of QTc prolongation on ribociclib
Measured: One visit at baseline before ribociclib start and then day 14+/-3 and day 28+/-3 after ribociclib start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start28 Jul 2023
- Primary completion8 Oct 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe Elie SALEM, MD.PhD, Principal investigator, Groupe Hospitalier Pitie-SalpetriereJean Michel VANNETZEL, MD, Principal investigator, Groupe Ambroise Paré, HartmannAlessandro VIANSONE, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisJoseph GLIGOROV, MD, PhD, Principal investigator, Hôpital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623397
- Sponsor's protocol ID
- 2021/03
- Acronym
- QT-RIBRATING
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QT on RIBociclib measuRed by ArTificial INteliGence
- ClinicalTrials.gov ID
- NCT05623397
- Acronym / sponsor ID
- QT-RIBRATING / 2021/03
- Conditions
- Breast Cancer, Ribociclib
- Keywords
- Deep Learning, Ribociclib, QTc values
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 21 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.
"Deep-learning" is a fast-growing method of machine learning (artificial intelligence, AI) which is arousing the interest of the scientific committee in many medical fields. These methods make it possible to generate matches between raw inputs (such as the digital signal from the ECG) and the desired outputs (for example, the measurement of QTc). Unlike traditional machine learning methods, which require manual extraction of structured and predefined data from raw input, deep-learning methods learn these functionalities directly from raw data, without pre-defined guidelines. With the advent of big-data and the recent exponential increase in computing power, these methods can produce models with exceptional performance. The investigators recently used this type of method using multi-layered artificial neural networks, to create an application based on a model that directly transforms the raw digital data of ECGs (.xml) into a measure of QTc comparable to those respecting the highest standards concerning reproducibility.
The main purpose of this trial is to study the performance of our DL-AI model for QTc measurement (vs. best standards of QTc measurements, TCM) applied to the recommended ECG monitoring following ribociclib prescription for breast cancer patients in routine clinical care. The investigators will acquire ECG with diverse devices including simplified devices (one/three lead acquisition, low frequency sampling rate: 125-500 Htz) to determine if they'll be equally performant versus 12-lead acquisition machine to evaluate QTc in this setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients administered ribociclib. | – | Other: Acquisition of a digitized ECG by four modalities within 20 minutesProspective cohort of consecutive breast cancer patients requiring ribociclib for their standard of care at the clinically indicated dose, as per treating physician prescription (600mg to 200mg/day for 21 days per 28 days cycle). Association with other hormone-derived therapeutics will be allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients requiring ribociclib for their standard of care at the clinically indicated dose, as per treating physician. Association with other hormone-derived therapeutics will be allowed.
Key inclusion criteria (3 listed)
- Adult female patients requiring start of ribociclib based therapy for a breast cancer in their standard of care, as per their summary of product characteristic's indications
- Association with hormone-based therapy in combination is authorized (aromatase inhibitors or fulvestrant)
- Able to provide an informed consent
Key exclusion criteria (5 listed)
- Any allergy or contra-indication to ribociclib as mentioned in their as summary of product characteristic's
- Patients presenting a condition precluding accurate QTc measurements on electrocardiogram, i.e paced ventricular rhythm, multiples premature ventricular or supra-ventricular contractions, ventricular tachycardia, supraventricular arrhythmia (including atrial fibrillation, flutter or junctional rhythm)
- Patients with an atrial pacing and sinus dysfunction
- Patients presenting a contra-indication for ECG measurement, or with a device rendering ECG measurements impossible (i.e. Diaphragmatic pacing)
- Patients presenting a contra-indication to ribociclib start; including association with prohibited drug potentializing the risk of TdP
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 |
|---|---|---|
| Acquisition of a digitized ECG by four modalities within 20 minutesPatients will have three visits during the cycle for a given dose (600mg/day, 400mg/day or 200mg/day): Baseline , Day 14, Day 28 At each visit, the patient will have the acquisition of a digitized ECG by four modalities within 20 minutes (A 10 second triplicate ECG with WELCH-ALYN ELI-280® with the three 10 sec ECGs collected at approximatively 2-minute intervals, 3 min holter acquisition with a CGM HI-patch ®, a 3 minutes acquisition with AliveCore 6L® device and 10 seconds triplicate acquisition with QT-medical ® device collected at approximatively 2-minute intervals ). Concomitantly with the ECG acquisition, patients will have blood sampling for measurements of variables clinically important for assessment of QTc including potassium, fasting blood glucose, calcemia, magnesium, estradiol, progesterone, FSH, LH, D4-androstenedione, total and free testosterone, SHBG and TSH. Blood concentration of ribociclib will be also assessed. | Other | Breast cancer patients administered ribociclib. |
Primary outcome
Compare the values of QTc generated by method 1 (overlap method on triplicate of 10 seconds ECG concatenated, TCM; the method of reference) versus method 2 relying on AI methodology in patients' candidate for ribociclib start
Time frame: One visit the day of ribociclib start (before ribociclib intake)
Comparison of the 2 methods (TCM vs. DL-AI) to demonstrate if there is a clinically relevant mean QTc difference ≥ 5msec between the 2 methods.
4 secondary outcomes
Compare the values of QTc generated by method 1 (overlap method after triplicate concatenation, TCM) versus method 2 (DL-AI) in patients' on/off ribociclib using a digitized 12-lead acquisition ECG device
Time frame: One visit at day 14+/-3 and day 28+/-3 after start of ribociclib
Compare the values of QTc generated using method 2 (DL-AI) in patients' on/off ribociclib using a miniaturized and/or simplified ECG acquisition device (QT-Medical®, AliveCor®, a holter system (CGM HI-patch) versus using a digitized 12-lead acquisition
Time frame: One visit at baseline before ribociclib start and then day 14+/-3 and day 28+/-3 after ribociclib start
The clinico-demographic predictors of amplitude of QTc prolongation on ribociclib.
Time frame: One visit at baseline before ribociclib start and then day 14+/-3 and day 28+/-3 after ribociclib start
Learn ECG features at baseline using deep-learning predictors of magnitude of QTc prolongation on ribociclib
Time frame: One visit at baseline before ribociclib start and then day 14+/-3 and day 28+/-3 after ribociclib start
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 3 Jun 2026.
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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.
Joe Elie SALEM, MD.PhD principal investigator
Groupe Hospitalier Pitie-Salpetriere
Jean Michel VANNETZEL, MD principal investigator
Groupe Ambroise Paré, Hartmann
Alessandro VIANSONE, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Ribociclib, run by CMC Ambroise Paré at 4 sites in France.
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 3 inclusion and 5 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Compare the values of QTc generated by method 1 (overlap method on triplicate of 10 seconds ECG concatenated, TCM; the method of reference) versus method 2 relying on AI methodology in patients' candidate for ribociclib start (time frame: One visit the day of ribociclib start (before ribociclib intake)). 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 3 Jun 2026; AzTrials last refreshed its copy on 4 Nov 2026.