Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction

NCT06065358 | Active Not Recruiting

• 1 other identifier: 4128
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window. For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of Chemotherapeutic Drug Effects on Ovarian Cancer Cell Cultures

  To establish the role of organotypic tumor slice cultures in newly diagnosed advanced ovarian tumors. To evaluate the feasibility of organotypic tumor slice cultures by measuring cell culture viability and the possibility of testing chemotherapeutic drugs.

  Baseline

Study Arms (1)

Interventional, prospective, monocentric

EXPERIMENTAL

Procedure: Tumor biopsy

Interventions

Tumor biopsy PROCEDURE

Patients with advanced suspected HGSOC will be considered eligible (FIGO stage from III C or greater). At the time of surgery, patients' disease extension will be assessed with the Fagotti score (PIV) and the Vizzielli score (VS). Only patients who are not considered operable in the first place, will be enrolled. Samples will be taken during surgery that will take place in the operating rooms of oncological gynaecology.

Interventional, prospective, monocentric

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer;
• Age over 18 years;
• Estimated life expectancy of at least 4 weeks;
• Fagotti score (PIV) \> 8 or patients not considered operable in the first place for any reasons;
• Histologic diagnoses of epithelial ovarian cancer at frozen section.

You may not qualify if:

• Non- epithelial histology at frozen section;
• Patients enrolled in other clinical trials.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Camilla Nero

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: October 3, 2023
• Study Start: September 13, 2021
• Primary Completion: October 13, 2023
• Study Completion (Estimated): August 3, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)