Recruiting NCT06229522

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

— Observational Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Primary outcome measures

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. [Time frame: up to 36 months]
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. [Time frame: up to 36 months]
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. [Time frame: up to 36 months]
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. [Time frame: up to 36 months]

Eligibility criteria

Inclusion criteria

Signed informed consent form;
Female sex;
Age ≥18 years;
Diagnosis of ovarian cancer;
Availability of tumor sample or ascites that is planned to be stored in the Institutional Biobank for research purpose

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Italy · 1 center

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano

Identifiers

NCT: NCT06229522 · CRO-2022-45

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗