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临床试验/NCT03456791
NCT03456791已完成不适用

Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Disease and Endometrial Cancer

Ain Shams University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年12月1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
84
试验地点
1
主要终点
Relation between preoperative level of human epididymis protein 4 and surgicopathological staging of endometrial carcinoma

研究概览

简要总结

Endometrial cancer represents the most common gynecologic cancer, and it is expected to become an even greater public health concern as the prevalence of obesity, one of the most common risk factors for endometrial cancer, increases worldwide.

Almost 20% of patients with endometrial cancer are in the premenopausal state and 10% are asymptomatic. In such a case, it is much harder to make an early diagnosis and usually they are probably diagnosed at advanced stages.

An earlier diagnosis represents an imperative goal to improve survival and prognosis of patients of endometrial cancer. Actually, there are no certified screening tools for endometrial cancer. Pelvic ultrasound as screening for endometrial cancer-reaches 80.5% of sensitivity, when endometrial echo is > 5 mm, but it dramatically decreases to 20% in asymptomatic women; moreover, specificity is low (61%).

详细描述

Human epididymis protein 4, a putative protease inhibition containing two Whey Acid Protein domains, is significantly increased in the endometrioid subtype of endometrial carcinoma.

Tissue microarray and polymerase chain reaction studies confirmed a high level of human epididymis 4 expression in both endometrioid and serous types of endometrial carcinoma , these results are consistent with those from other laboratories showing increased human epididymis protein 4 messenger ribonucleic acid and protein expression in endometrial cancer tissues.

Subsequent investigation demonstrated that human epididymis protein 4 are detectable in various normal tissues with varying expression levels, yet their levels are significantly increased in endometrial carcinoma compared to normal endometrium.

Human epididymis protein 4 ( HE4) is a member of the whey-acidic protein family and it is . Human epididymis protein 4 was first isolated from the human epididymis .

This protein is also known as epididymal secretory protein E4, major epididymis specific protein E4 and putative protease inhibitor WAP5. WFDC-2 gene product was originally thought to be a protein specifically expressed in the epididymis and was dubbed as a tissue marker for the same.

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
45 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age (45 - 70 yr old).

排除标准

  • Age more than 70 yr and less than 40 yr.
  • Abnormal cardiac hematological renal hepatic functions.
  • Breast cancer or other malignancies.
  • Concomitant benign and for malignant adnexal pathologies.
  • Hormonal medication.
  • Patient taking or having chemo-radiotherapy.
  • Patients unfit for surgical intervention.

结局指标

主要结局

Relation between preoperative level of human epididymis protein 4 and surgicopathological staging of endometrial carcinoma

时间窗: one week

following staging laparotomy for cases of endometrial carcinoma , the result of pathology will be correlated to HEP4

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

Hayam Fathy Mohammad

Assisted professor of obstetrics and gynecology

Ain Shams University

研究点 (1)

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