Paired Biopsies to Develop a Cellular Signature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pearson correlation for changes between kinome and CA125
研究概览
简要总结
This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.
详细描述
Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.
The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.
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
- •Age ≥18 years.
- •Histological diagnosis of epithelial ovarian cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Life expectancy of greater than 3 months
- •Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
- •Must be agreeable to paired biopsies
- •Must have disease amenable to paired biopsy.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Any contraindication to biopsy
- •Need for anticoagulation that cannot be interrupted
结局指标
主要结局
Pearson correlation for changes between kinome and CA125
时间窗: 5 years
Paired T-test for differences in kinome between responders and non-responders
时间窗: 5 years
次要结局
未报告次要终点