Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- To test the effect of chemotherapeutic drugs on ovarian cancer cell cultures.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
- •Age over 18 years;
- •Estimated life expectancy of at least 4 weeks;
- •Fagotti score (PIV) > 8 or patients not considered operable in the first place for any reasons;
- •Histologic diagnoses of epithelial ovarian cancer at frozen section.
排除标准
- •Non- epithelial histology at frozen section;
- •Patients enrolled in other clinical trials.
研究组 & 干预措施
Interventional, prospective, monocentric
干预措施: Tumor biopsy (Procedure)
结局指标
主要结局
To test the effect of chemotherapeutic drugs on ovarian cancer cell cultures.
时间窗: 24 months
To evaluate the concordance of chemotherapy drug response in ovarian cancer patients treated in vivo and in cell culture of tumor tissue harvested and treated in vitro.
Evaluation of Chemotherapeutic Drug Effects on Ovarian Cancer Cell Cultures
时间窗: Baseline
To establish the role of organotypic tumor slice cultures in newly diagnosed advanced ovarian tumors. To evaluate the feasibility of organotypic tumor slice cultures by measuring cell culture viability and the possibility of testing chemotherapeutic drugs.
次要结局
未报告次要终点