跳至主要内容
临床试验/NCT06420427
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

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

发起方
The Third Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng Xiujie

Professor

The Third Affiliated Hospital of Guangzhou Medical University

研究点 (1)

Loading locations...

相似试验

Dynamic Monitoring of ctDNA and HPV DNA in Plasma... | 临床试验