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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: up to 36 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

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

Идентификаторы

NCT: NCT06229522 · CRO-2022-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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