Document is current
Any future updates will be listed below
-
Authors
Budillon, Alfredo
Leone, Alessandra
Passaro, Eugenia
Silvestro, Lucrezia
Foschini, Francesca
Iannelli, Federica
Roca, Maria Serena
Macchini, Marina
Bruzzese, Francesca
Garcia Bermejo, Maria Laura
Rodriguez Garrote, Mercedes
Tortora, Giampaolo
Milella, Michele
Reni, Michele
Fuchs, Claudia
Hewitt, Eve
Kubiak, Christine
Di Gennaro, Elena
Giannarelli, Diana
Avallone, Antonio
-
Funding
Funding for this research was provided by:
European Union’s Horizon Europe research and innovation (101057442)
Ministero della Salute (RF-2021-12371995)
- License Information
-
More Information
Article History
Received: 3 September 2024
Accepted: 11 September 2024
First Online: 19 September 2024
Declarations
:
: This study was approved by the Certified independent Ethical Committee of the Istituto Nazionale Tumori IRCCS G. Pascale (Determina Dirigenziale 13/03/2023 N.358) and by the Italian and Spanish regulatory drug bodies AIFA and AEMPS. Approval was confirmed by institutional Review Boards of all participating centers. The procedures set out in this study protocol are designed to ensure that the principles of the Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH) and the Declaration of Helsinki are respected in the conduct, evaluation and documentation of this study. Participants will provide written informed consent prior to participation in this study. The study started in June 2023. It is planned that patient’s enrollment will be completed in 30 months with an expected total study duration of approximately 40 months, considering an additional 10 months of follow up from last patient enrolled. At the moment 69 patients were screened and 63 enrolled. The study was registered in EU Clinical Trial Register (EudraCT 2022-004154-63) and in ClinicalTrial.gov (NCT05821556).
: The authors declare no competing interests.
