Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: up to 36 months
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.
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.
时间窗: up to 36 months
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
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.
时间窗: up to 36 months
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
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.
时间窗: up to 36 months
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.
次要结局
未报告次要终点