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临床试验/NCT03459976
NCT03459976Unknown不适用

HE4 is a Beneficial Biomarker in Endometrial Cancer

Ain Shams University1 个研究点 分布在 1 个国家目标入组 87 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
入组人数
87
试验地点
1
主要终点
: Evaluation of Serum Level of(HE4) in Benign Endometrial disease and Endometrial Cancer

研究概览

简要总结

Evaluation of Serum level of Human Epididymis Secretory Protein 4 (HE4) in Endometrial Cancer and clinical significant it

详细描述

.Endometrial cancer represents the most common gynecologic cancer, and it is expected to become an even greater public health concer as the prevalence of obesity, one of the most common risk factors for endometrial cancer, increases worldwide, Approximately 42,160 cases are diagnosed annually, 7,780 deaths occur, and more than 4,000 new cases are diagnosed yearly (Renehan et al., 2008).

National Cancer Institute (NCI) statistics shows that while there was an. insignificant decline in the incidence of endometrial cancer (EC) from 1997 to 2006 (-0.4 annual percentage change), the mortality rate increased significantly in the same time period (+0,3 annual percentage change). These data seem to suggest a trend for an increasing frequency of more aggressive forms of EC in the United States, which underscores the need for a better understanding of the molecular mechanisms and pathways involved in EC pathogenesis (National Cancer Institute, 2013).

The diagnosis is usually done at an early stage, and approximately 70% of endometrial cancers are diagnosed as stage I; this results in better prognosis, with a 5-year overall survival rate of 90% to 95% (Jemal et al., 2009).

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 (Li et al., 2009).

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%) (Jacobs et al., 2011).

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

入选标准

  • Age (40 - 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

: Evaluation of Serum Level of(HE4) in Benign Endometrial disease and Endometrial Cancer

时间窗: 1 yeare

* Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Endometrial Cancer Disease and * Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Endometrial Cancer Disease and c: Evaluation of Serum Human Epididymis Secretory Protein 4 (HE4) in Benign Endometrial Endometrial Cancer Disease and cas cotrol study

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

f m dabnon

dr.fatma mohamed dapnon abuktaa

Ain Shams University

研究点 (1)

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