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NCT Number: NCT07757711

Implementation of New Models of Ovarian Carcinoma Resistant to Therapy

The project focuses on developing new experimental models of ovarian cancer that accurately reflect patients who do not respond to first-line platinum-based treatments and who are resistant to PARP inhibitors (PARPi). These models are essential for testing new drugs or drug combinations in preclinical settings that closely mimic real clinical conditions. These models will also help to identify predictive biomarkers of treatment response and to better understand the biological mechanisms behind therapy resistance.

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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 and older

Sex eligibility

Female

Study type

Observational

About this study

The aims of the present project are:

  • to generate new experimental models from biopsies of ovarian cancer patients whose tumors are either refractory to platinum-based therapy or have relapsed during or after treatment with platinum and PARPi;
  • molecularly, and pharmacologically characterize these models, including patient-derived xenografts (PDXs) grown in immunodeficient animals, organoids (3D in vitro models) and primary cell cultures (2D) derived from the same biopsies;
  • to use these models to identify new biomarkers of therapy response, study resistance mechanisms, and design preclinical trials for new therapeutic strategies; The study involves transplanting fresh tumor tissue into immunodeficient mice to create PDX models, as well as generating organoids and cell cultures. It will run for 10 years and include adult female patients (aged 18 or older) with recurrent ovarian cancer treated at the European Institute of Oncology, who have given informed consent. Clinical and pathological data will be collected at enrollment and during follow-up and stored in a coded database.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients with malignant ovarian gynecological disease.
  • Age 18 years or older.
  • Patients capable of providing informed consent.

Exclusion criteria

-Failure to sign the informed consent form.

Treatment and study plan

Platinum drugs and PARPi

Other

Patients with ovarian carcinoma resistant to platinum drugs and PARPi undergoing paracentasis and/or surgical with left-over tumor material.

Primary outcomes

  1. To obtain new in vivo experimental models of ovarian carcinomas

    Time frame: 10 years

    To obtain new experimental models from biopsies of ovarian carcinomas that are refractory to platinum-based therapy and recurrent during or after treatment with platinum-based therapy and PARP inhibitors, as treated at the Division of Medical Gynecologic Oncology of the European Institute of Oncology.

    To this end, a portion of the neoplastic tissue will be transplanted subcutaneously into at least two immunodeficient mice and follwed for tumor appearance

  2. To obtain new in vitro experimental models of ovarian carcinomas

    Time frame: 10 years

    To obtain new experimental models from biopsies of ovarian carcinomas that are refractory to platinum-based therapy and recurrent during or after treatment with platinum-based therapy and PARP inhibitors, as treated at the Division of Medical Gynecologic Oncology of the European Institute of Oncology. To this end, a portion of the neoplastic tissue will digest with collagesase and single cell suspension obtained and seeded with specific mediums suplemented with growth factors in vitro to obtain primary cultures and organoids

Secondary outcomes

  1. Pharmacological characterization of the obtained models: in vivo outcomes

    Time frame: 10 years

    The obtained patient derived xenografts (PDX) will be used to test the antitumor activity of platinum drugs and polyADP rybose polymearse inhibitors. The efficiacy of drug treatments will be evaluated calculating the percentage of tumor growth inhibition in mice treated with the anticancer agents compared with untreated controls, assessed by measuring tumor volume (mgr) using a Vernier caliper, following the formula: (Vtreated/Vuntreated)*100. V=tumor volume

  2. Pharmacological characterization of the obtained models: in vivo outcomes

    Time frame: 10 years

    Percentage of increase in overall survival in PDX-bearing mice treated with anticancer agents compared with untreated controls. by the formula (Median survival time in drug treated mice - Median survival time of vehicle treated control mice)/Median survival time of of vehicle treated control mice.

  3. Pharmacological characterization of the obtained models: in vitro outcomes

    Time frame: 10 years

    In vitro outcomes:

    IC50 values (50% inhibitory concentration) of different anticancer agents (platinum drugs, PARP inhibitors, and taxanes) evaluated in 3D models and primary cultures using validated cytotoxicity assays.

  4. Molecular identification of potential biomarker of response

    Time frame: 10 years

    Immunohistochemical (IHC) dection of several proteins in 3D cultures and PDXs models using validated IHC antibodies

  5. Molecular identification of potential biomarker of response

    Time frame: 10 years

    Quantification of mRNA expression levels by quantitative PCR of different genes

Study contacts

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

Giovanna Damia, MD

CONTACT

[email protected]

+30 02 39014234 ext. 4234

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • Istituto Europeo di Oncologia

Registry information

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

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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