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Spots Global Cancer Trial Database for A Deep Learning Method to Evaluate QT on Ribociclib

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Trial Identification

Brief Title: A Deep Learning Method to Evaluate QT on Ribociclib

Official Title: QT on RIBociclib measuRed by ArTificial INteliGence

Study ID: NCT05623397

Study Description

Brief 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 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Groupe Ambroise Paré, Hartmann, Neuilly-sur-Seine, , France

Hôpital Tenon, Paris, , France

CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE, Paris, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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