Ovarian CancerNCT07757711
Implementation of New Models of Ovarian Carcinoma Resistant to Therapy
An observational study of Ovarian Cancer, run by Mario Negri Institute for Pharmacological Research.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Platinum drugs and PARPi
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Aug 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Female patients with malignant ovarian gynecological disease.
- Age 18 years or older.
- Patients capable of providing informed consent.
Who cannot join
- -Failure to sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Ovarian Cancer
- Being tested
- Platinum drugs and PARPi
- Keywords
- Ovarian cancer, Resistance, Platinum drug, Parp inhibitors
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platinum drugs and PARPiOther
Patients with ovarian carcinoma resistant to platinum drugs and PARPi undergoing paracentasis and/or surgical with left-over tumor material.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ovarian carcinoma | Patients with ovarian carcinoma resistant to platinum drugs and PARPi Receives: Other: Platinum drugs and PARPi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 years
Secondary outcomes (5)
Pharmacological characterization of the obtained models: in vivo outcomes
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
Measured: 10 years
Pharmacological characterization of the obtained models: in vivo outcomes
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.
Measured: 10 years
Pharmacological characterization of the obtained models: in vitro outcomes
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.
Measured: 10 years
Molecular identification of potential biomarker of response
Immunohistochemical (IHC) dection of several proteins in 3D cultures and PDXs models using validated IHC antibodies
Measured: 10 years
Molecular identification of potential biomarker of response
Quantification of mRNA expression levels by quantitative PCR of different genes
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2036 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Europeo di Oncologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757711
- Sponsor's protocol ID
- IMOVAReT
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of New Models of Ovarian Carcinoma Resistant to Therapy
- ClinicalTrials.gov ID
- NCT07757711
- Acronym / sponsor ID
- IMOVAReT
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Resistance, Platinum drug, Parp inhibitors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Istituto Europeo di Oncologia
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2036 (estimated)
- Study completion
- 31 Aug 2036 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ovarian carcinoma | – | Other: Platinum drugs and PARPiPatients with ovarian carcinoma resistant to platinum drugs and PARPi |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female patients with malignant ovarian gynecological disease.
- Age 18 years or older.
- Patients capable of providing informed consent.
Key exclusion criteria (1 listed)
- -Failure to sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platinum drugs and PARPiPatients with ovarian carcinoma resistant to platinum drugs and PARPi undergoing paracentasis and/or surgical with left-over tumor material. | Other | Patients with ovarian carcinoma |
Primary outcome
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
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
5 secondary outcomes
Pharmacological characterization of the obtained models: in vivo outcomes
Time frame: 10 years
Pharmacological characterization of the obtained models: in vivo outcomes
Time frame: 10 years
Pharmacological characterization of the obtained models: in vitro outcomes
Time frame: 10 years
Molecular identification of potential biomarker of response
Time frame: 10 years
Molecular identification of potential biomarker of response
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Mario Negri Institute for Pharmacological Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Damia, MD (+30 02 39014234 ext. 4234, giovanna.damia@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain new in vivo experimental models of ovarian carcinomas (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.