Using patient-derived organoids to predict treatment response in ovarian cancer
Patients Derived Organoids (PDOs) Immune Cells Co-culture in Ovarian Cancer: the Role of TUmoR microEnvironment.
This study is testing whether lab-grown mini-tumors from ovarian cancer patients can help predict how well they will respond to different cancer treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Roma) |
| Trial ID | NCT06085404 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of using patient-derived organoids (PDOs) in co-culture with immune cells from ovarian cancer patients. By mimicking the tumor's architecture and drug response, the study seeks to establish a correlation between the sensitivity of these organoids to treatments and the actual in vivo responses observed in patients. If successful, PDOs could serve as a reliable tool for predicting how individual patients will respond to antineoplastic drugs, potentially improving treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of FIGO stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer.
Not a fit: Patients with non-serous histology or those undergoing immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide personalized treatment predictions for ovarian cancer patients, leading to more effective therapies.
How similar studies have performed: While the use of PDOs in cancer research is gaining traction, this specific application in ovarian cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma
- Policlinico Universitario Agostino Gemelli — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Camilla Nero — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Camilla Nero, PhD
- Email: camilla.nero@policlinicogemelli.it
- Phone: +390630158667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.