Translational Analysis In Longitudinal Series of Ovarian Cancer ORganoids

Summary

This is a longitudinal observational phase II, single center, single arm study on the reliability of high grade serous ovarian carcinoma organoids obtained from primary debulking surgery (PDS)+adjuvant chemotherapy and neoadjuvant chemotherapy + interval debulking surgery (NACT+IDS) cases as model for the patients' response to treatments. Since organoids represent a model system comparable to patient-derived xenografts, the investigators tested the null hypothesis that the possibility of correctly identifying the drug-sensitivity could improve from 80%, as assessed by xenografts to at least 95%. The first step was planned to include 7 patients; if 5 or more patients do not respond, the trial will be terminated. If the trial goes on to the second stage, a total of 43 patients will be studied. Considering a patient dropout of approximately 10%, the study was planned to enroll at least 48 patients.

Conditions

• Organoids
• Epithelial Ovarian Cancer

Interventions

PROCEDURE

Tumor biopsy

Both interventions performed at baseline upon study enrolment (pre- and post-NACT for NACT+IDS patients) and at the time of recurrence. 1. 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). 2. Blood samples will be collected to purify extracellular circulating RNA (cRNAs).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Principal Investigators

• Giuseppe Vizzielli, PhD · Fondazione Policlinico "A. Gemelli" IRCCS

• Giovanni Scambia, Professor · Fondazione Policlinico "A. Gemelli" IRCCS - Università Cattolica del Sacro cuore

• Claudio Sette, Professor · Catholic University of the Sacred Heart

• Camilla Nero, PhD · Fondazione Policlinico "A. Gemelli" IRCCS

• Eleonari Cesari, PhD · Catholic University of the Sacred Heart

• Salvatore Gueli Alletti, MD · Fondazione Policlinico "A. Gemelli" IRCCS

• Marco Pieraccioli, PhD · Catholic University of the Sacred Heart

• Carolina Bottoni, MD · Fondazione Policlinico "A. Gemelli" IRCCS

• Carmine Conte, MD · Fondazione Policlinico "A. Gemelli" IRCCS

• Matteo Loverro, MD · Catholic University of the Sacred Heart

• Anna Fagotti, Professor · Catholic University of the Sacred Heart

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-12

Primary Completion

2021-11-04

Completion

2023-05-04

Countries

• Italy

Study Locations