Patients Derived Organoids in Ovarian Cancer

NCT ID: NCT06085404

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-25

Study Completion Date

2025-11-25

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional

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

Group Type OTHER

Blood sample

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Tumor Biopsy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camilla Nero

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Camilla Nero, PhD

Role: CONTACT

+390630158667

Facility Contacts

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Camilla Nero, PhD

Role: primary

0630158667

Other Identifiers

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4531

Identifier Type: -

Identifier Source: org_study_id

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