Patients Derived Organoids in Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: Blood sample

• Registration Number: NCT06085404
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-25
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-04-30
• Study Completion: 2025-11-25

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. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Blood sample	-

Primary Outcome Measures

Name	Time	Method
To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model.	24 months	To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model, organoids, aimed at obtaining information on the genomic and molecular characteristics of tumor cells and cells belonging to the immune system specific to each individual ovarian cancer patient and to study their interaction.

Trial Locations

Locations (1)

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Italy