Ovarian Cancer
Conditions
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.
Interventions
PROCEDUREBlood sample
Patients will be enrolled starting right after Ethics Committee approval. Samples will be taken during surgery that will take place in the operating rooms of oncological gynecology.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants are prospectively assigned to an intervention consisting of a blood draw and tumor biopsy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactCamilla Nero, PhD
Outcome results
None listed