Patients Derived Organoids in Ovarian Cancer

Ovarian Cancer Clinical Trial

— PICTURE  

Official title:

Patients Derived Organoids (PDOs) Immune Cells Co-culture in Ovarian Cancer: the Role of TUmoR microEnvironment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085404
• Other study ID #: 4531
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Camilla Nero, PhD
• Phone: 0630158667
• Email: camilla.nero[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Blood 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.

Locations

Country	Name	City	State
Italy	Policlinico Universitario Agostino Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model.	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.	24 months