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临床试验/NCT06125886
NCT06125886尚未招募不适用

A Multicenter Clinical Study on Endometrial Cancer Screening in High-risk Populations in China

Peking University People's Hospital0 个研究点目标入组 22,000 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
22,000
主要终点
sensitivity and specificity

研究概览

简要总结

Endometrial cancer is one of the most common malignancies of the reproductive system. The incidence of endometrial cancer has increased in recent years. No effective, low-cost screening method for populations at high risk exists.

The traditional methods of endometrial cancer screening and diagnosis (segmented scraping and hysteroscopic biopsy) are invasive examinations with high medical costs. It is urgent to establish a reasonable, effective, economical, and non-invasive endometrial cancer screening strategy. This study aims to evaluate the effectiveness and feasibility of transvaginal ultrasound and microscale endometrial sampling biopsy in screening for endometrial precancerous lesions and endometrial cancer among high-risk populations in China, and to conduct cost-effectiveness analysis of different screening strategy, ultimately guiding the development of screening strategies that are suitable for high-risk populations in China.

详细描述

The enrolled patients underwent simultaneous transvaginal ultrasound examination and microscale endometrial sampling biopsy.

After enrollment, a vaginal ultrasound examination was performed to record the thickness of the endometrium, whether there were uterine cavity masses, endometrial unevenness, and endometrial blood flow. If any of the following occurs, it is considered a positive screening result:

A. Premenopausal women with endometrial thickness greater than 8mm B. Postmenopausal endometrial thickness>4mm C. Uneven endometrium D. Abnormal echo in the uterine cavity E. Endometrium or uterine cavity with abundant blood flow (RI ≤ 0.45) If the above situation does not occur, it is considered as negative for transvaginal ultrasound screening.

After completing the transvaginal ultrasound examination, the patient used Li rush in the diagnostic room to obtain endometrial tissue samples and conduct pathological examination of the endometrial tissue.

A. Not satisfied with the specimen (mucus or hemorrhagic necrotic tissue) or insufficient sampling (only a small amount of endometrial tissue can be seen, less than 5 endometrial glands cannot be diagnosed by pathology) or no endometrial components are found, and a small amount of cervical tissue is scraped B. Normal proliferative phase, secretory phase, atrophic endometrium C. Without atypical endometrial proliferative lesions D. Suspected malignant tumor cells and tissue components E. Atypical endometrial hyperplasia/EIN or endometrial cancer If result A appears, it is considered a failure to obtain the sample, and if result B appears, it is considered a negative screening result. C. The results of D and E are considered positive for screening.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

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

  • Age ≥ 45 years old
  • Hypertension
  • Obesity (BMI ≥ 28)
  • History of estrogen application without progesterone antagonism
  • Polycystic ovary syndrome
  • Functional ovarian tumors (ovarian tumors that secrete estrogen) before surgical treatment
  • Infertility
  • During tamoxifen treatment, long-term use of mifepristone (greater than 3 months)
  • Abnormal uterine bleeding or vaginal discharge
  • Postmenopausal vaginal bleeding or vaginal discharge
  • Hereditary non polyposis colorectal cancer (HNPCC) patients over 35 years old, or patients with a family history of colorectal cancer or endometrial cancer
  • Cervical cytology examination indicates atypical glandular cells (AGC)
  • Previous history of ovarian cancer or breast cancer

排除标准

  • Body temperature ≥ 37.5 ℃
  • Acute and subacute reproductive tract inflammation
  • Suspected pregnancy
  • Clearly diagnosed patients with malignant tumors of the reproductive tract
  • Acute severe systemic disease

结局指标

主要结局

sensitivity and specificity

时间窗: 2 years

Evaluate the sensitivity and specificity of transvaginal ultrasound and endometrial microstructural pathology examination for endometrial cancer screening in high-risk populations, and determine the most effective screening mode

次要结局

  • cost-effectiveness analysis(2 years)

研究者

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

Wang Jianliu

professor

Peking University People's Hospital

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