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AI reads heart signals to simplify cancer drug monitoring

NCT ID NCT05623397

Knowledge-focused Sponsor: CMC Ambroise Paré Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether an artificial intelligence (AI) model can accurately measure heart rhythm changes (QTc) from ECGs in 70 breast cancer patients starting the drug ribociclib. The goal was to see if simpler ECG devices could work as well as standard 12-lead machines when analyzed by AI. The findings could make heart monitoring easier and more accessible during cancer treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

70 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Ribociclib

Contacts and locations

Locations

  • CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE

    Paris, 75651, France

  • Groupe Ambroise Paré, Hartmann

    Neuilly-sur-Seine, 92200, France

  • Hôpital Tenon

    Paris, 75020, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

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