RecruitingRecruiting
Patients Derived Organoids in Ovarian Cancer
NCT06085404 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
In plain English
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Official title
Patients Derived Organoids (PDOs) Immune Cells Co-culture in Ovarian Cancer: the Role of TUmoR microEnvironment.
About this study
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 criteria
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
Enrollment target: 48 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-11-25
Estimated completion: 2025-11-25
Last updated: 2025-03-04
Interventions
Procedure: Blood sample
Primary outcomes
- • To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model. (24 months)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · other
Contacts & investigators
ContactCamilla Nero, PhD · contact · camilla.nero@policlinicogemelli.it · +390630158667
InvestigatorCamilla Nero · principal_investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
All locations (1)
Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy