PIK3CA Mutational Status Assessment: Towards a "Tailored" Diagnostic Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.
研究概览
简要总结
Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.
详细描述
Evaluate the effectiveness and concordance of molecular methods in identifying mutations affecting the PIK3CA gene both on paraffin tissue sections of the tumor and on liquid biopsy of patients with breast cancer treated at the IEO. The molecular test on the liquid biopsy of same patient could bring an important benefit considering that the withdrawal of this biomaterial turns out to be less invasive than a biopsy performed on an organ
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
- •Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
- •Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
- •Participants should be at advanced or metastatic setting prior to treatment.
- •Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- •Patients must be accessible for follow-up.
排除标准
- •patients already treated with different treatments like chemotherapy, hormone therapy etc
结局指标
主要结局
Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.
时间窗: 2 years
Investigate concordance between sequencing panels again generation (NGS) based on different principles and different RT-PCR assays in detecting mutations of PIK3CA.
次要结局
未报告次要终点