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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

About this study

Most patients with ovarian cancer (OC) present with advanced stage and severe symptoms. The standard of care is based on an association between surgery and platinum-based chemotherapy, to which targeted therapies have been added since 2014. Despite significantly improved outcomes, there are still 15-20% of patients resistant to platinum-based chemotherapy without many therapeutic options and poor prognosis. It is urgent to select this population thus limiting useless undesirable effects and exploring more effective therapeutic options before clinical conditions worsen. To date, there are no validated predictive markers of primary platinum refractory or resistant disease and traditional cancer models are currently incompatible with treatment time window in this clinical setting.

Among cancer models, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Evaluation of Chemotherapeutic Drug Effects on Ovarian Cancer Cell Cultures

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: TOSCA

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2026
First posted: Oct 3, 2023
Registry last updated: Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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