Mes données de santé
The information site for patients treated within the Unicancer network or included in Unicancer network clinical trials. 

About us

Objectives

Primary objective

Comparison of the prevalence of molecular alterations between the post-treatment versus pre-treatment tumor samples of all patients.

 

Secondary objectives

* Comparison of the prevalence of molecular alterations between the post-treatment versus pre-treatment tumor samples of patients with paired samples (post- and pre-treatment)

* Identification of molecular alterations in the pre-treatment samples associated with the clinical benefit (RECIST responses, progression-free survival PFS)

* Identification of expression signature in the pre-treatment samples associated with the clinical benefit (RECIST1.1 responses, progression-free survival PFS)

* Identification of molecular alterations therapeutically “actionable” (therapeutic target of or marker predictive for response to currently available or under development drugs) in the post- and the pre-treatment samples

*Percentage of patients with molecular alterations therapeutically “actionable” in the post- and the pre-treatment samples

Data controller

Institut Paoli Calmettes

232 Boulevard Sainte Marguerite

13273 Marseille Cedex 09

Categories of data used
Données d’identification (sans donnée nominative) / Données de santé / Données génétiques / Antécédents familiaux
Origine de données utilisées
Soins
Institut Paoli Calmettes (Marseille)
Population subject to research or data processing

The main inclusion criteria include female patients previously treated in our institution, with pathologically-proven HR+/HER2- mBC, treated with hormone therapy combined with CDK4/6 inhibitors, with a metastatic/tumor sample (FFPE and/or frozen) available and collected before and/or after this treatment, with clinico-pathological annotations including the dates of treatments, objective responses, and progression-free survival, and with signed informed consent for enrolment and molecular analyses. All patients v and not lost to follow-up will be sent an individual information note before launching the project to advertise them of the project.

Legal basis

Traitement de données mené dans l'intérêt public dans le domaine de la santé publique (article 6.1e et 9.2.j du Règlement (UE) n°2016/679)

Internal and external data recipients

Institut Paoli Calmettes

Research start date
08/07/2021
Data retention period

Les données seront conservées pendant la durée légale en vigueur ou tant qu'elles présenteront un intérêt scientifique 

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