NCT04353557招募中不适用
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
Geneplus-Beijing Co. Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Positive ctDNA detection at first post-operative timepoint
研究概览
简要总结
This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years old
- •Histologically proven primary breast cancer with clinical stage I-III
- •Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).
- •Expected to achieve R0 resection.
- •Estimated lifetime is more than 3 months.
- •Signed Informed Consent Form
- •Consent to provide research blood samples.
排除标准
- •Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or
- •Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status
- •Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.
- •Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
结局指标
主要结局
Positive ctDNA detection at first post-operative timepoint
时间窗: 1 month post-surgery
The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint
次要结局
- Positive ctDNA detection at post-operative timepoints(6/12/18/24/30 months)
- Association between ctDNA detection and time to recurrence(6/12/18/24/30 months)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
ctDNA as a Biomarker for Treatment in Advanced NSCLCNon-small Cell Lung CancerNCT05486988Fuzhou General Hospital500
招募中
不适用
Dynamic Monitoring of ctDNA Methylation to Predict Relapse in Colorectal Cancer After Radical Resection (POSTCA)Circulating Tumor DNASurveillanceMethylationColorectal CancerNCT03737539Fudan University300
已完成
不适用
Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast CancerCirculating Tumor DNAGene AbnormalityMetastatic Breast CancerNCT05427617Hunan Cancer Hospital223
已完成
不适用
Clinical Application of Circulating Tumor DNA (ctDNA) in Patients With Late-stage Breast CancerCirculating Tumor DNAGene AbnormalityMetastatic Breast CancerNCT05079074Hunan Cancer Hospital223
尚未招募
不适用
Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian CancerOvarian CancerNCT05976932Fudan University20