A Prospective, Multicenter Cohort Study of Urinary Exosome lncRNAs for Preoperative Diagnosis of Lymphatic Metastasis in Patients With Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Lymph node metastases in bladder cancer
研究概览
简要总结
Bladder cancer is one of the most frequent malignant tumors of the urinary system in China, seriously threatening the life safety of patients. The main treatment methods for bladder cancer include surgical resection, radiotherapy and chemotherapy, immunotherapy, and targeted therapy, among which surgical resection is still the only reliable radical treatment at present. Lymphatic metastasis is the main mode of metastasis of bladder cancer, and preoperative diagnosis is of great significance to determine whether radical surgical treatment can be performed for some patients with advanced bladder cancer. Recent studies reveal that exosomes, as key signaling molecules in the tumor microenvironment, have been confirmed to be associated with various tumor progressions. Our previous study showed that lncRNA-ELNAT1 highly expressed in urine exosomes of bladder cancer patients can promote lymphatic metastasis of bladder cancer by inducing lymphatic angiogenesis, and is associated with poor prognosis of patients. However, whether exosome ELNAT1 can be used as an independent preoperative predictor of lymph node metastasis of bladder cancer needs to be explored in further clinical trials, and this study will further clarify the association between the two. In this study, urine exosomes were collected from positive and negative control patients with lymph node metastasis of bladder cancer, and the ROC curve was statistically analyzed and fitted to determine whether exosome ELANT1 could be used as an independent predictor of lymph node metastasis of bladder cancer.
详细描述
- According to the selection criteria. Bladder cancer patients with informed consent in the study were first included.
- The patients with indications of radical cystectomy were selected.
- Urine samples were collected before radical cystectomy and exocrine bodies were extracted to analyze the expression level of ELNAT1
- According to the postoperative lymph node pathological results, the above patients were further divided into two groups：lymphatic metastasis positive group and negative group.
- We perform statistical analysis of urinary exosomal ELNAT1 to validate the performance of diagnosing lymphatic metastasis of bladder 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old
- •Clinically diagnosed urothelial carcinoma bladder cancer
- •Patients agreed to provide the urine sample
- •Patients who voluntarily agreed to informed consent
排除标准
- •Patients with distant metastasis
- •Patients with uncontrolled viral infection (HIV, HBV, HCV)
- •Patients who are pregnant, or have the possibility of pregnancy and are on lactating
- •Hypersensitivity or history of allergic to the drug being used
- •Patients with cerebrovascular disease, complications, and infections that are not medically controlled
- •Patients with a history of other malignant diseases within the past 5 years (excluding cured non-melanoma skin cancer or in situ cervical cancer)
- •Those who are taking drugs that can cause drug interactions with chemotherapy
- •Patients who withdraw consent
结局指标
主要结局
Lymph node metastases in bladder cancer
时间窗: 1 years
Analyses of number and location of lymph node metastases based on pathological diagnosis
次要结局
- recurernce rate(3 years)