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

Not Applicable

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: Tumor biopsy

• Registration Number: NCT06065358
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

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.

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.

Study Timeline

• Study Start: 2021-09-13
• Status Verified: 2023-03
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03
• Primary Completion: 2023-10-13
• Study Completion: 2023-12-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional, prospective, monocentric	Tumor biopsy	-

Primary Outcome Measures

Name	Time	Method
To test the effect of chemotherapeutic drugs on ovarian cancer cell cultures.	24 months	To evaluate the concordance of chemotherapy drug response in ovarian cancer patients treated in vivo and in cell culture of tumor tissue harvested and treated in vitro.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy