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临床试验/NCT02605941
NCT02605941Unknown不适用

DNA Methylation Biomarkers for Cervical Cancer Screening

iStat Biomedical CO., Ltd.1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,000
试验地点
1
主要终点
Performance of DNA methylation in identification of CIN3 or worse.

研究概览

简要总结

The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.

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
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women with age ≥20 and sexual experience
  • Agree to sign ICF

排除标准

  • women had received Hysterectomy
  • women had destructive therapy for cervical lesions in 6 months, for examples: conization, Laser or cryotherapy, chemotherapy, and radiation therapy
  • Women are at pregnancy or had baby delivery in 6 weeks

结局指标

主要结局

Performance of DNA methylation in identification of CIN3 or worse.

时间窗: 3 years

Patient's information, including clinical diagnosis and the molecular testing results etc., will be collected. Performances of the screening tools will be compared.

次要结局

未报告次要终点

研究者

发起方
iStat Biomedical CO., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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