Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Epithelial Ovarian Cancer
  • Organoids
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 75 years
Gender
Only males

Description

In this project, the investigators propose to employ the patients-derived organoid technology to test HGSOC organoids obtained from PDS+adjuvant chemotherapy and NACT+IDS cases to predict patients' response to treatments; moreover, the investigators aim to study genomic and phenotypic evolution of H...

In this project, the investigators propose to employ the patients-derived organoid technology to test HGSOC organoids obtained from PDS+adjuvant chemotherapy and NACT+IDS cases to predict patients' response to treatments; moreover, the investigators aim to study genomic and phenotypic evolution of HGSOC organoids from PDS+adjuvant chemotherapy and NACT+IDS patients undergoing relapse. Finally, the investigators intend to investigate splicing-targeting technologies as new potential therapeutic treatments to increase vulnerability of HGSOCs. FIGO stage IIIC or IV ovarian, fallopian tube, or primary peritoneal cancer patients will be included if disease at metastatic sites is supposed to be completely resectable and they will be triaged for staging laparoscopy to obtain histologic diagnosis and to provide the tumor load assessment through the laparoscopic score. If PDS is chosen, open cytoreduction will be performed at the same time and bioptic tissue will be collected for organoids; otherwise, women will be submitted to NACT followed by IDS and tissue for organoids will be collected from both staging LPS biopsy (pre-) and subsequent surgery (post-NACT). Part of each surgical specimen will be used to obtain organoids, whereas part will be frozen for direct comparative analysis of the original tumor. 1-6 organoids from each patient will be prepared from PDS or NACT-IDS patients (pre- and post-NACT) and blood samples will also be collected to purify extracellular circulating RNA (cRNAs).

Tracking Information

NCT #
NCT04555473
Collaborators
Not Provided
Investigators
Principal Investigator: Giuseppe Vizzielli, PhD Fondazione Policlinico "A. Gemelli" IRCCS Study Director: Giovanni Scambia, Professor Fondazione Policlinico "A. Gemelli" IRCCS - Università Cattolica del Sacro cuore Study Director: Claudio Sette, Professor Catholic University of the Sacred Heart Study Chair: Camilla Nero, PhD Fondazione Policlinico "A. Gemelli" IRCCS Study Chair: Eleonari Cesari, PhD Catholic University of the Sacred Heart Study Chair: Salvatore Gueli Alletti, MD Fondazione Policlinico "A. Gemelli" IRCCS Study Chair: Marco Pieraccioli, PhD Catholic University of the Sacred Heart Study Chair: Carolina Bottoni, MD Fondazione Policlinico "A. Gemelli" IRCCS Study Chair: Carmine Conte, MD Fondazione Policlinico "A. Gemelli" IRCCS Study Chair: Matteo Loverro, MD Catholic University of the Sacred Heart Study Chair: Anna Fagotti, Professor Catholic University of the Sacred Heart