Dréno, Brigitte http://orcid.org/0000-0001-5574-5825
Khammari, Amir http://orcid.org/0000-0001-9328-8004
Fortun, Agnès
Vignard, Virginie
Saiagh, Soraya
Beauvais, Tiffany
Jouand, Nicolas
Bercegay, Sylvain
Simon, Sylvain
Lang, François http://orcid.org/0000-0002-0762-4647
Labarrière, Nathalie http://orcid.org/0000-0002-1407-6546
Funding for this research was provided by:
INCA/PHRC (RC12_0261)
LabEx IGO (ANR-11-LABX-0016-01)
Ligue Contre le Cancer
Article History
Received: 5 January 2021
Accepted: 6 May 2021
First Online: 12 June 2021
Declarations
:
: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
: The trial complied with all French (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM, « loi n°2012-300, 5 Mars 2012, relative aux recherches impliquant la personne humaine», and all its amendments) and European requirements for the conduct of clinical trials (European Medicine Agency, EMA, CPMP/ICH/377/95, EMEA) and all the principles of Good clinical practices, the 1964 Declaration of Helsinki, received approval for all study sites from the ethics committee of Rennes, France (CPP Ouest V- Rennes; réf CPP: 14/19-935) and is registered at ClincalTrials.gov under the identifier: NCT02424916.
: All patients provided written informed consent prior to inclusion.