Patients Derived Organoids in Ovarian Cancer

NCT06085404 | Recruiting

• 1 other identifier: 4531
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Interventional

OTHER

Participants are prospectively assigned to an intervention consisting of a blood draw and tumor biopsy.

Procedure: Blood sample

Interventions

Blood sample PROCEDURE

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.

Also known as: Tumor Biopsy

Interventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Histologic diagnoses of epithelial ovarian cancer at frozen section
• Age \>18 and years;
• Estimated life expectancy of at least 4 weeks;
• Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) \< 2

You may not qualify if:

• Non-serous histology at frozen section;
• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Camilla Nero

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Nero, PhD

CONTACT

+390630158667; camilla.nero@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are prospectively assigned to an intervention consisting of a blood draw and tumor biopsy.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: October 17, 2023
• Study Start: November 25, 2021
• Primary Completion: April 30, 2025
• Study Completion: November 25, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)