Using deep learning to evaluate QT intervals in breast cancer patients on ribociclib
QT on RIBociclib measuRed by ArTificial INteliGence
This study is testing a new way to use computer technology to check heart health in women with breast cancer who are starting treatment with ribociclib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | CMC Ambroise Paré Academic / other |
| Locations | 4 sites (Neuilly-sur-Seine and 3 other locations) |
| Trial ID | NCT05623397 on ClinicalTrials.gov |
What this trial studies
This observational study employs deep learning techniques to analyze electrocardiogram (ECG) data for measuring QTc intervals in adult female patients starting ribociclib therapy for breast cancer. The study aims to utilize advanced machine learning algorithms that can directly interpret raw ECG signals without the need for predefined data extraction methods. By leveraging big data and enhanced computational power, the researchers hope to develop a model that accurately assesses QTc values, which are crucial for monitoring cardiac health in patients undergoing treatment. The study will involve acquiring digitized ECGs through various modalities within a short timeframe.
Who should consider this trial
Good fit: Ideal candidates include adult female patients who are starting ribociclib therapy for breast cancer and can provide informed consent.
Not a fit: Patients with conditions that prevent accurate QTc measurements or those with contraindications to ribociclib will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate monitoring of cardiac health in breast cancer patients receiving ribociclib, potentially improving patient safety and treatment outcomes.
How similar studies have performed: While deep learning applications in medical diagnostics are gaining traction, this specific approach to QT evaluation in the context of ribociclib therapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Neuilly-sur-Seine and 3 other locations
- Groupe Ambroise Paré, Hartmann — Neuilly-sur-Seine, France (Recruiting)
- Hôpital Tenon — Paris, France (Recruiting)
- CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE — Paris, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Joe Elie SALEM, MD.PhD
- Email: joeelie.salem@gmail.com
- Phone: (+33)1 46 41 89 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.