跳至主要内容
临床试验/NCT06001099
NCT06001099招募中不适用

Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study

Fudan University1 个研究点 分布在 1 个国家目标入组 2,935 人开始时间: 2023年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,935
试验地点
1
主要终点
To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies

研究概览

简要总结

This study is a prospective study aimed to validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 2935 female participants, including participants with gynecologic cancers patients and healthy participants.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies

时间窗: 24 months

次要结局

  • To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors(24months)
  • To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.(24months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhong Zheng MD

Department of Gynecological Oncology, Fudan University Shanghai Cancer Center

Fudan University

研究点 (1)

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