NCT06420427招募中不适用
Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment
The Third Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年1月1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
- 150
- 试验地点
- 1
- 主要终点
- sensitivity
研究概览
简要总结
Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.
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
- 否
入选标准
- •Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
- •Patients must be older than 18 years of age.
- •Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy.
- •Estimated life expectancy of more than three months.
- •Understands the study protocol and voluntarily participates in the research by signing the informed consent form.
- •Able to provide specimens and corresponding clinical information at each time point.
排除标准
- •Patients who are participating in other clinical trials.
- •Pregnant or breastfeeding women.
- •Patients with severe mental illness.
- •Patients who voluntarily withdraw.
- •Patients unable to complete the study protocol.
结局指标
主要结局
sensitivity
时间窗: 2 year
true positive rate
次要结局
未报告次要终点
研究者
Sheng Xiujie
Professor
The Third Affiliated Hospital of Guangzhou Medical University
研究点 (1)
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