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Active, not recruiting Not applicable

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

NCT06065358 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-09-13
Last updated
2026-04-24

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Tumor biopsy

Tumor biopsy: 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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. Age over 18 years; 3. Estimated life expectancy of at least 4 weeks; 4. Fagotti score (PIV) \> 8 or patients not considered operable in the first place for any reasons; 5. Histologic diagnoses of epithelial ovarian cancer at frozen section. Exclusion Criteria: 1. Non- epithelial histology at frozen section; 2. Patients enrolled in other clinical trials.

Primary outcome measure(s)

  • Evaluation of Chemotherapeutic Drug Effects on Ovarian Cancer Cell Cultures — Baseline
    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.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06065358 on ClinicalTrials.gov ↗ ← All trials in Italy