Prospective Study on the Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes
研究概览
简要总结
Breast cancer is the most common malignant tumor in women worldwide,and there exist a large part of patients need to receive neoadjuvant chemotherapy(NAC) before the curative surgery.Circulating tumor DNA(ctDNA) is the circulating free DNA in the blood that originates from cancers,and it can be detected by modern technologies in plasma.In this prospective study,investigators aim to observe the correlation between tumor response to neoadjuvant chemotherapy and ctDNA.
详细描述
Women with node-positive breast cancer are at high risk for recurrence. Neoadjuvant chemotherapy is traditionally for locally advanced disease, converting an inoperable tumor to a resectable one.In the present study, investigators will focus on breast cancer patients whose primary tumors are large or have lymph node metastases and need to receive neoadjuvant chemotherapy from 2018 to 2019. Circulating tumor DNA(ctDNA) will be obtained from peripheral blood,and the blood samples will be taken before the neoadjuvant chemotherapy、during the chemotherapy、 before the surgery and post surgery visit (within 24 hours after surgery) .Investigators will collect tissue samples both from the breast lump biopsy and the curative surgery. Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to monitor the efficacy of neoadjuvant chemotherapy in breast cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients undergoing neoadjuvant chemotherapy
- •Age: 18-70 yrs
- •Any menopausal status
- •Any hormone receptor status
- •Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):
- •Locally advanced tumor
- •Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.
排除标准
- •Failed to retain blood sample before NAC
- •Lost more than 2 blood samples during NAC
结局指标
主要结局
dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes
时间窗: From patients recruited into the research until the surgury complete ,assessed up to 26 weeks.
To assess the changes of ctDNA mutant copies during the process of our observation,and to find out the relationship between ctDNA and tumor response to neoadjuvant chemotherapy
次要结局
- disease free survival after surgery(Up to 5 years)
研究者
Zhiyong Yu
Director of the Breast Surgery Ⅰ
Shandong Cancer Hospital and Institute