A Deep Learning Method to Evaluate QT on Ribociclib (QT-RIBRATING)

June 1, 2026 updated by: CMC Ambroise Paré

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Neuilly-sur-Seine, France, 92200
        • Groupe Ambroise Paré, Hartmann
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75651
        • CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Acquisition of a digitized ECG by four modalities within 20 minutes

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One visit the day of ribociclib start (before ribociclib intake)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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).
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
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®).
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
Nonlinear mixed models will be used to study clinico-demographic determinants associated with magnitude of QTc prolongation on ribociclib.
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
Using deep-learning seeking for a model using ECG raw data at baseline to predict magnitude of QTc prolongation on ribociclib
One visit at baseline before ribociclib start and then day 14+/-3 and day 28+/-3 after ribociclib start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CMC Ambroise Paré

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Groupe Hospitalier Pitie-Salpetriere

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joe Elie SALEM, MD.PhD, Groupe Hospitalier Pitie-Salpetriere
  • Principal Investigator: Jean Michel VANNETZEL, MD, Groupe Ambroise Paré, Hartmann
  • Principal Investigator: Alessandro VIANSONE, MD, Gustave Roussy, Cancer Campus, Grand Paris
  • Principal Investigator: Joseph GLIGOROV, MD, PhD, Hopital Tenon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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