NCT06085404 Patients Derived Organoids in Ovarian Cancer
| NCT ID | NCT06085404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2021-11-25 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2021-11-25 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Camilla Nero
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06085404 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06085404 currently recruiting?
Yes, NCT06085404 is actively recruiting participants. Contact the research team at camilla.nero@policlinicogemelli.it for enrollment information.
Where is the NCT06085404 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06085404 clinical trial?
NCT06085404 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Camilla Nero at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 48 participants.
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