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Trial Title:
Patients Derived Organoids in Ovarian Cancer
NCT ID:
NCT06085404
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Blood sample
Description:
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.
Arm group label:
Interventional
Other name:
Tumor Biopsy
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Policlinico Universitario Agostino Gemelli
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Camilla Nero, PhD
Phone:
0630158667
Email:
camilla.nero@policlinicogemelli.it
Start date:
December 20, 2021
Completion date:
December 20, 2023
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085404
