N° 21516972

Validation of an AI algorithm for predicting survival (overall and specific), recurrence, and therapeutic response in patients with cutaneous melanoma. Multicenter study.

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Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Recherche, étude, évaluation

Objectifs poursuivis

Diagnostics

Domaines médicaux investigués

Cancérologie

Bénéfices attendus

Primary: Evaluate the performance of AI applied to histological images in predicting survival and therapeutic response in patients with cutaneous melanoma from multiple independent, multicenter cohorts.

Secondary : Validate the robustness and generalizability of the algorithm on melanomas from different centers and determine the impact of using AI on clinical decision-making by comparing the results with traditional evaluation methods.

Données utilisées

Catégories de données utilisées

Informations relatives aux pathologies des personnes concernées

Source de données utilisées

Autre

Autre(s) source(s) de donnée(s) mobilisée(s)

Dossiers Médicaux

Appariement entre les sources de données mobilisées

  Non

Plateforme utilisée pour l'analyse des données

Autre

Acteurs finançant et participant à l'étude

Responsable(s) de traitement

Type de responsable de traitement 1

Start-up

Responsable de traitement 1

DiaDeep

24 Rue du Dauphiné 69003 69003 Lyon France

Localisation du responsable de traitement 1
  Dans l'UE
Représentant du responsable de traitement 1

Calendrier du projet

Date de début : 17/01/2025 – Date de fin : 17/01/2026 Durée de l'étude : 24
Etape 1 : Dépôt du projet
17/12/2024

Base légale pour accéder aux données

Encadrement réglementaire

Méthodologie de référence 004

Durée de conservation aux fins du projet (en années)

2

Existence d'une prise de décision automatisée

  Non

Fondement juridique

Article 6 du RGPD (Licéité du traitement)

(1)(f) intérêts légitimes du responsable de traitement

Article 9 du RGPD (Exception permettant de traiter des données de santé)

(2)(j) archives, recherche scientifique ou historique, ou statistiques

Transfert de données personnelles vers un pays hors UE

  Oui

If as part of the processing activities described above, DiaDeep needs to transfer Personal Data from Data Subjects established in the European Economic Area (“EEA”) to recipient(s) located outside of the European Economic Area, such as its service providers and/or its partners and/or its affiliates, DiaDeep will ensure that adequate and appropriate safeguards are implemented as required by the GDPR (e.g. ensuring an adequacy decisions from the European Commission is in force in accordance with Article 45 of the GDPR, or binding legal act or European Commission Standard Contractual Clauses have been signed with the recipient where applicable).

Droits des personnes

Confirmation and Access Right Data Subjects have the right to request confirmation from DiaDeep about whether their Personal Data is being processed. They are also entitled to access this data and to request a copy, provided electronically in a commonly used format unless otherwise specified.

Updating and Rectification Rights Data Subjects can request that DiaDeep rectify their Personal Data if it is inaccurate, incomplete, or obsolete.

Right to Oppose to the Processing Activities Data Subjects have the right to oppose the processing of their Personal Data, especially when it does not pertain to compliance with a legal obligation or the establishment, exercise, or defense of legal claims.

Right to Deletion Data Subjects may request the deletion of their Personal Data under certain conditions, such as when the data is no longer necessary for the purposes for which it was collected or processed, or when the processing lacks a legal basis following the withdrawal of consent.

Rights to Restrict Processing The right to restrict processing applies unless DiaDeep's processing is necessary to comply with legal obligations or for the performance of its services.

Personal Data Portability Right Upon request, DiaDeep will facilitate the portability of Personal Data in situations where the processing is based on consent and the data was provided by the Data Subjects through online services.

Délégué à la protection des données

DiaDeep

24 rue du dauphiné 69003 Lyon France

m.pham@diadeep.com