Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA).

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentro di Riferimento Oncologico - Aviano

About this trial

The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and/or promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form;

Female sex;

Age ≥18 years;

Diagnosis of ovarian cancer;

Disqualifiers

Patients for which the tumor/ascites biobanking process could compromise the diagnostic assessments;

Pregnancy or breast-feeding

History of concomitant or previous malignancy in the last 5 years

Trial population

This study will include all consecutive women with a diagnosis of ovarian cancer who fit all inclusion/exclusion criteria between the date in which the study is approved and December 2027. Follow-up information will be collected up to 10 years since enrollment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

To assess if the drugs' sensibility tested in the 3D organoids derived from biopsies could predict the clinical response (PFS) to therapy regimen for each individual ovarian cancer patient.

Patients will be divided into two groups based on IC50 level. Difference in PFS probability between patients with high or low IC50 level will be assessed. Progression-free survival (PFS) will be defined as time from enrolment to progression or death whichever comes first

Time frame
up to 36 months
2

To assess if the drugs' sensibility tested in the 3D organoids derived from ascites fluids could predict the clinical response (PFS) to therapy regimen for each individual ovarian cancer patient.

Patients will be divided into two groups based on IC50 level. Difference in PFS probability between patients with high or low IC50 level will be assessed. Progression-free survival (PFS) will be defined as time from enrolment to progression or death whichever comes first

Time frame
up to 36 months
3

To assess if the drugs' sensibility tested in the 3D organoids derived from biopsies could predict the clinical response (PFI) to therapy regimen for each individual ovarian cancer patient.

Patients will be divided into two groups based on IC50 level. Difference in platinum-free interval for platinum salts (PFI) probability between patients with high or low IC50 level will be assessed. PFI will be defined as time from the date of last dose of first line chemotherapy to the date of first recurrence.

Time frame
up to 36 months
4

To assess if the drugs' sensibility tested in the 3D organoids derived from ascites fluid could predict the clinical response (PFI) to therapy regimen for each individual ovarian cancer patient.

Patients will be divided into two groups based on IC50 level. Difference in platinum-free interval for platinum salts (PFI) probability between patients with high or low IC50 level will be assessed. PFI will be defined as time from the date of last dose of first line chemotherapy to the date of first recurrence.

Time frame
up to 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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