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Recruiting NCT06085404

Patients Derived Organoids in Ovarian Cancer

No phase Interventional Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model. [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • Policlinico Universitario Agostino Gemelli — Roma

Identifiers

NCT: NCT06085404 · 4531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗