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Trial Title:
Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction
NCT ID:
NCT06065358
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor biopsy
Description:
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.
Arm group label:
Interventional, prospective, monocentric
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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;
2. Age over 18 years;
3. Estimated life expectancy of at least 4 weeks;
4. Fagotti score (PIV) > 8 or patients not considered operable in the first place for
any reasons;
5. Histologic diagnoses of epithelial ovarian cancer at frozen section.
Exclusion Criteria:
1. Non- epithelial histology at frozen section;
2. Patients enrolled in other clinical trials.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Camilla Nero, PhD
Phone:
0630158667
Email:
camilla.nero@policlinicogemelli.it
Start date:
September 13, 2021
Completion date:
December 13, 2023
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06065358
