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临床试验/NCT03155451
NCT03155451已完成不适用

Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Pathological diagnosis of ovarian lumps

研究概览

简要总结

Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA.This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

详细描述

Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.

ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and the fact that ctDNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.

This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

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 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • people aged 18years to 80years;
  • Diagnosis of ovarian cancer is confirmed by two Pathologists independently;
  • Pregnancy tests are negative.

排除标准

  • With other type of malignancies;
  • someone who refuse to participate the study.

结局指标

主要结局

Pathological diagnosis of ovarian lumps

时间窗: One week after surgery

Pathological diagnosis of ovarian lumps,including immunohistochemical information and HE staining information.

次要结局

  • sensitivity (true positive rate)(2 year)
  • Specificity (true negative rate)(2 year)

研究者

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

Wang Yu

M.D.

RenJi Hospital

研究点 (1)

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