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临床试验/NCT05749341
NCT05749341Enrolling By Invitation不适用

A Pilot Study of Liquid Biopsy Diagnostic Techniques for Endometriosis

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Percentage of cases with identified circulating endometrial cells.

研究概览

简要总结

To evaluate the diagnostic efficiency of circulating endometrial cell detection method using microfluidic chip as an non-invasive method for diagnosis in endometriosis.

详细描述

Endometriosis is a chronic condition, characterized by the presence of functional endometrial glands and interstitium in extrauterine ectopia. Ectopic endometrial tissue responds to estradiol and other hormones similar to normal endometrium. Endometriosis is one of the most common benign gynaecological conditions, affecting up to 5 to 10 percent of women of reproductive age. In addition to severe dysmenorrhea or pelvic pain, decreased fertility is a common clinical manifestation of internal heterogeneity, with up to 40 percent of patients associated with infertility . Currently, laparoscopy is the gold standard for diagnosis. However, the actual time to diagnosis in patients with internal dysmorphia is delayed by an average of 4 to 11 years, resulting in a large number of patients with moderate to severe (stage III to IV) at diagnosis. Recently, the exploration of efficient and cost-effective non-invasive diagnostic solutions has been a hot button issue.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Surgically and pathologically verified patients with or without endometriosis

排除标准

  • suspicion of malignancy
  • pregnancy
  • acute infection
  • Lack of ability to sign informed consent forms on their own

结局指标

主要结局

Percentage of cases with identified circulating endometrial cells.

时间窗: within one week after blood sample collecting

To evaluate the ability of the Three-Dimensional Poly(dimethylsiloxane) Scaffold to isolating circulating endometrial cells (CEC) in patients with and without endometriosis. In each group, the percentage of cases with identified circulating endometrial cells will be estimated.

次要结局

未报告次要终点

研究者

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

Wenwen Wang

associate professor

Tongji Hospital

研究点 (1)

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