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Patients Derived Organoids in Ovarian Cancer

Patients Derived Organoids (PDOs) Immune Cells Co-culture in Ovarian Cancer: the Role of TUmoR microEnvironment.

NCT06085404•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

Among cancer models, patients derived organoids (PDOs) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response. For these reasons, it has been designed a study to assess the feasibility of PDOs immune cells co-culture in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, PDOs could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.

Eligibility

Age

18 - 80 years

Sex

FEMALE

Healthy Volunteers

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. Histologic diagnoses of epithelial ovarian cancer at frozen section
•3. Age \>18 and years;
•4. Estimated life expectancy of at least 4 weeks;
•5. Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) \< 2

Exclusion Criteria

•1. Non-serous histology at frozen section;
•2. Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (\> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.

Locations (1)

Policlinico Universitario Agostino Gemelli

Roma, Italy

Key Dates

Start Date

November 25, 2021

Primary Completion Date

April 30, 2025

Completion Date

November 25, 2025

Last Updated

March 4, 2025

Enrollment

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

Blood sample

PROCEDURE

Contacts

Camilla Nero, PhD

CONTACT

+390630158667 camilla.nero@policlinicogemelli.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Patients Derived Organoids in Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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