Ovarian CancerTOSCANCT06065358
Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction
A study testing Tumor biopsy in people with Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Tumor biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2021to 3 Aug 2026
- Phase
- Interventional
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Age over 18 years;
- Estimated life expectancy of at least 4 weeks;
- Fagotti score (PIV) > 8 or patients not considered operable in the first place for any reasons;
- Histologic diagnoses of epithelial ovarian cancer at frozen section.
Who cannot join
- Non- epithelial histology at frozen section;
- Patients enrolled in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.
For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.
Read the detailed description
Most patients with ovarian cancer (OC) present with advanced stage and severe symptoms. The standard of care is based on an association between surgery and platinum-based chemotherapy, to which targeted therapies have been added since 2014. Despite significantly improved outcomes, there are still 15-20% of patients resistant to platinum-based chemotherapy without many therapeutic options and poor prognosis. It is urgent to select this population thus limiting useless undesirable effects and exploring more effective therapeutic options before clinical conditions worsen. To date, there are no validated predictive markers of primary platinum refractory or resistant disease and traditional cancer models are currently incompatible with treatment time window in this clinical setting.
Among cancer models, ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.
For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.
- Conditions
- Ovarian Cancer
- Being tested
- Tumor biopsy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyProcedure or surgery
Patients with advanced suspected HGSOC will be considered eligible (FIGO stage from III C or greater). At the time of surgery, patients' disease extension will be assessed with the Fagotti score (PIV) and the Vizzielli score (VS). Only patients who are not considered operable in the first place, will be enrolled. Samples will be taken during surgery that will take place in the operating rooms of oncological gynaecology.
| Study group | Role | What they receive |
|---|---|---|
| Interventional, prospective, monocentric | Experimental | Not described Receives: Procedure: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Chemotherapeutic Drug Effects on Ovarian Cancer Cell Cultures
To establish the role of organotypic tumor slice cultures in newly diagnosed advanced ovarian tumors. To evaluate the feasibility of organotypic tumor slice cultures by measuring cell culture viability and the possibility of testing chemotherapeutic drugs.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start13 Sep 2021
- Primary completion13 Oct 2023
- Study completion3 Aug 2026 (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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilla Nero, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065358
- Sponsor's protocol ID
- 4128
- Acronym
- TOSCA
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction
- ClinicalTrials.gov ID
- NCT06065358
- Acronym / sponsor ID
- TOSCA / 4128
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 3 Aug 2026 (estimated)
- First posted
- 3 Oct 2023 (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.
Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.
For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.
Detailed description
Most patients with ovarian cancer (OC) present with advanced stage and severe symptoms. The standard of care is based on an association between surgery and platinum-based chemotherapy, to which targeted therapies have been added since 2014. Despite significantly improved outcomes, there are still 15-20% of patients resistant to platinum-based chemotherapy without many therapeutic options and poor prognosis. It is urgent to select this population thus limiting useless undesirable effects and exploring more effective therapeutic options before clinical conditions worsen. To date, there are no validated predictive markers of primary platinum refractory or resistant disease and traditional cancer models are currently incompatible with treatment time window in this clinical setting.
Among cancer models, ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.
For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional, prospective, monocentric | Experimental | Procedure: Tumor biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Age over 18 years;
- Estimated life expectancy of at least 4 weeks;
- Fagotti score (PIV) > 8 or patients not considered operable in the first place for any reasons;
- Histologic diagnoses of epithelial ovarian cancer at frozen section.
Key exclusion criteria (2 listed)
- Non- epithelial histology at frozen section;
- Patients enrolled in other clinical trials.
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 |
|---|---|---|
| Tumor biopsyPatients with advanced suspected HGSOC will be considered eligible (FIGO stage from III C or greater). At the time of surgery, patients' disease extension will be assessed with the Fagotti score (PIV) and the Vizzielli score (VS). Only patients who are not considered operable in the first place, will be enrolled. Samples will be taken during surgery that will take place in the operating rooms of oncological gynaecology. | Procedure or surgery | Interventional, prospective, monocentric |
Primary outcome
Evaluation of Chemotherapeutic Drug Effects on Ovarian Cancer Cell Cultures
Time frame: Baseline
To establish the role of organotypic tumor slice cultures in newly diagnosed advanced ovarian tumors. To evaluate the feasibility of organotypic tumor slice cultures by measuring cell culture viability and the possibility of testing chemotherapeutic drugs.
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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Camilla Nero principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor biopsy in people with Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Chemotherapeutic Drug Effects on Ovarian Cancer Cell Cultures (time frame: Baseline). 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 24 Apr 2026.