Prospective Study to Correlate the Treatment Sensitivity of Patient-derived Organoids With Clinical Outcomes in Breast Cancer Patients With Brain and/or Extra-cranial Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient derived organoids
研究概览
简要总结
The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases. The preliminary data collected will be used to assess the ability of PDOs to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome.
详细描述
The SOTO-BC trail is an observation study and the patients will continue their clinical visits and follow-up as per normal standard of care.
Patient cohorts:
- Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy)
- Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
Primary objective:
To assess the percentage of successful generated organoids from resected brain or resected/biopsied extra-cranial metastases of breast cancer 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
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients with brain metastases who are suitable for surgical resection or Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
- •Age > 18 years old
排除标准
- •Patients unable to give informed consent e.g., mental disability or vulnerable adults
结局指标
主要结局
Patient derived organoids
时间窗: 10 months
To generate PDOs from brain or extra-cranial metastases of breast cancer patients.
次要结局
- recurrence and survival rates(4 months)
- Response to radiotherapy(6 months)
- Response to therapy(5 months)
- Response rate of patients undergoing systemic treatment(3 months)