跳至主要内容
临床试验/NCT03881384
NCT03881384招募中不适用

Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients During Neoadjuvant Chemotherapy

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
The concentration of circulating DNA(ctDNA)

研究概览

简要总结

In nonmetastatic local advanced breast cancer patients, we are going to investigate whether circulating tumor DNA (ctDNA) detection can reflect the tumor response to neoadjuvant chemotherapy (NCT) and detect minimal residual disease after surgery.

详细描述

Breast cancer is the most common malignant tumor in women worldwide, and chemotherapy is still the main method of breast cancer treatment. And for locally advanced breast cancer patients, neoadjuvant chemotherapy can further improve treatment efficacy, improve prognosis and increase the rate of breast conserving surgery. The persistence of a minimal residual disease at distant sites after the treatment of a localized breast cancer is a key parameter for posttreatment survival but cannot be reliably assessed by the current biological or radiological tools. Therefore, the prediction of the chemotherapy efficacy is very important. ctDNA, corresponds to fragmented DNA released into the blood stream by tumor masses, the detection and quantification of circulating tumor DNA (ctDNA) is a very promising tool that can assess tumor burden, response to therapy, and minimal residual disease. In this study, we wil collect breast cancer cases treated with neoadjuvant chemotherapy, draw blood and evaluate the efficacy each time before chemotherapy and after surgery, then measure the concentration of ctDNA in each sample. We will also analyze the demographic data,basic treatment and follow-up data including relapse, metastasis and survival.

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

入选标准

  • Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer;
  • Tumor size ≥ 0.5cm (clinical or radiographic measurements);
  • Any nodal status allowed;
  • Age > 18 years old;
  • Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician;
  • ECOG score<=2;

排除标准

  • Known metastatic disease;
  • With serious heart, lung, liver diseases;
  • Poor cardiac function;
  • Pregnant;
  • Patients with other malignant tumor or treated before;

结局指标

主要结局

The concentration of circulating DNA(ctDNA)

时间窗: From date of neoadjuvant chemotherapy decided until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Take the blood each time before chemtherapy and measure the concentration of ctDNA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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