Informations générales (source: ClinicalTrials.gov)

NCT05623397 En recrutement IDF
QT on RIBociclib measuRed by ArTificial INteliGence (QT-RIBRATING)
Observational
CMC Ambroise Paré (Voir sur ClinicalTrials)
juillet 2023
septembre 2026
23 juillet 2024
"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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY Alessandro Adriano VIANSONE En recrutement IDF 19/06/2024 10:44:42  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Tenon Joseph GLIGOROV, MD, PhD En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE - 75651 - Paris - France Joe Elie SALEM, MD, PhD En recrutement Contact (sur clinicalTrials)
Groupe Ambroise Paré, Hartmann - 92200 - Neuilly-sur-Seine - France Jean Michel VANNETZEL, MD En recrutement Contact (sur clinicalTrials)

Critères

Femme
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


- 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