Forlani, Luca
De Cecco, Loris
Simeon, Vittorio
Paolini, Biagio
Bagnoli, Marina
Cecere, Sabrina Chiara
Spina, Anna
Citeroni, Eleonora
Bignotti, Eliana
Lorusso, Domenica
Arenare, Laura
Russo, Daniela
De Angelis, Carmine
Ardighieri, Laura
Scognamiglio, Giosuè
Del Sesto, Michele
Tognon, Germana
Califano, Daniela
Schettino, Clorinda
Chiodini, Paolo
Perrone, Francesco
Mezzanzanica, Delia
Pignata, Sandro
Tomassetti, Antonella https://orcid.org/0000-0001-6772-9937
Funding for this research was provided by:
Associazione Italiana per la Ricerca sul Cancro (IG19243, IG18921, IG25932)
Ministero della Salute (RF-2016-02363995, CO-2018-12367051, Ricerca Corrente, Ricerca Corrente M2/7)
Article History
Received: 26 August 2022
Accepted: 21 March 2023
First Online: 11 April 2023
Declarations
:
: MITO16A-ManGO OV-2 is a phase IV registered trial (EudraCT number: 2012–003043-29) that aims to explore the prognostic role of selected biomarkers in OC patients treated in first line with chemotherapy (Paclitaxel + Carboplatin × 6) plus BEV (15 mg/kg) for 15 months. The study has been approved by the Ethic Committee (first approval by the Ethic Committee of the proponent institute INT Pascale Napoli, Prot. #383/12 of 19 July 2012) and all patients provided written informed consent. In 2015, all research groups have been invited by the MITO Coordinator to review their applications according to new data meanwhile generated by their labs and/or updated literature and to check whether the proposed biomarkers could be still considered appropriate and/or whether new biomarkers should be added. This review process raised the need to modify and integrate the list of proposed biomarkers approved by the Ethic Committee in 2016. Informed consent was obtained from all subjects involved in the study.
: Not applicable.
: The MITO 16A-MaNGO OV2A is a multicenter national, academic trial sponsored by NCI Naples. Roche Italy granted the study with partial funding and BEVA provision. No other competing interests regarding this study are reported by the authors.