A Prospective Cohort Study of Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- The incidence of chemotherapy related adverse reaction
研究概览
简要总结
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.
The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
详细描述
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.
The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event.
We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
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
- 否
入选标准
- •Histologically diagnosed stage I-III breast cancer;
- •Plan to receive adjuvant chemotherapy in our hospital;
- •Sign the informed consent;
- •Good compliance and willing to follow up.
排除标准
- •Those who have started receiving adjuvant chemotherapy;
- •Chemotherapy contraindications;
结局指标
主要结局
The incidence of chemotherapy related adverse reaction
时间窗: 1 years
chemotherapy related adverse reaction are assessed by CTCAE protocol
次要结局
- disease free survival(5years)
研究者
Zhong-yu Yuan
Professor Zhongyu Yuan
Sun Yat-sen University