NCT07757711

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
123mo left

Started Aug 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2036

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

10.1 years

First QC Date

March 26, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Ovarian cancerResistancePlatinum drugParp inhibitors

Outcome Measures

Primary Outcomes (2)

  • To obtain new in vivo experimental models of ovarian carcinomas

    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

    10 years

  • To obtain new in vitro experimental models of ovarian carcinomas

    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

    10 years

Secondary Outcomes (5)

  • Pharmacological characterization of the obtained models: in vivo outcomes

    10 years

  • Pharmacological characterization of the obtained models: in vivo outcomes

    10 years

  • Pharmacological characterization of the obtained models: in vitro outcomes

    10 years

  • Molecular identification of potential biomarker of response

    10 years

  • Molecular identification of potential biomarker of response

    10 years

Study Arms (1)

Patients with ovarian carcinoma

Patients with ovarian carcinoma resistant to platinum drugs and PARPi

Other: Platinum drugs and PARPi

Interventions

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

Patients with ovarian carcinoma

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female with malignant gynecological cancers of ovarian origin refractory to platinum-based therapy or recurring during or after treatment with platinum and PARP inhibitors.

You may qualify if:

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

You may not qualify if:

  • Failure to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples and ascites

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

August 11, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 31, 2036

Study Completion (Estimated)

August 31, 2036

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

This is a biological study involving the transplantation of fresh tumor tissue into immunodeficient mice to generate new patient-derived xenograft (PDX) models of ovarian origin and new in vitro models. The study plans to enroll patients admitted to the Division of Medical Gynecologic Oncology at the European Institute of Oncology who have malignant gynecologic diseases of ovarian origin that are refractory to platinum-based therapy or have recurred during or after treatment with platinum and PARP inhibitors.