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NCT Number: NCT06085404

Patients Derived Organoids in Ovarian Cancer

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Universitario Agostino Gemelli

Roma, Italy

Location status: Recruiting

Location contact

Camilla Nero, PhD

CONTACT

[email protected]

0630158667

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Tumor Biopsy

Primary outcomes

  1. To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model.

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Nero, PhD

CONTACT

[email protected]

+390630158667

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PICTURE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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