Endometrial Cancer Screening in High-risk Populations

NCT06125886UNKNOWNNAINTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Peking University People's Hospital

Enrollment

22000

Start Date

2023-11-15

Completion Date

2024-12-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

transvaginal ultrasound and microscale endometrial sampling biopsy

Conditions

Cancer Screening

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

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

Exclusion Criteria:

1. Body temperature ≥ 37.5 ℃
2. Acute and subacute reproductive tract inflammation
3. Suspected pregnancy
4. Clearly diagnosed patients with malignant tumors of the reproductive tract
5. Acute severe systemic disease

Outcome Measures

Primary Outcomes

sensitivity and specificity

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

Time frame: 2 years

Secondary Outcomes

cost-effectiveness analysis

Using Quality Adjusted Life Year (QALY) as the effectiveness indicator, screening expenses (screening organization management expenses, testing and evaluation expenses, personal direct expenses, and personal indirect expenses) and treatment expenses (including hospitalization expenses, outpatient expenses, direct non medical expenses, and indirect expenses) as the cost of expenditure, Calculate the cost-effectiveness ratio of different screening modes (single B-ultrasound, single endometrial micro tissue examination, B-ultrasound+endometrial micro tissue examination, B-ultrasound endometrial micro tissue examination), and calculate the cost of each extended QALY for each group and the incremental cost-effectiveness ratio between each group, and compare it with the willingness to pay value (budget line).

Time frame: 2 years

Linked Papers

2021-02-05

Variations in incidence and mortality rates of endometrial cancer at the global, regional, and national levels, 1990–2019

Endometrial cancer (EC) is a commonly diagnosed cancer in women. A comprehensive knowledge of its epidemiological features is essential for understanding the disease burden and guiding prevention strategies. We retrieved the incidence and mortality data of EC from the Global Burden of Disease database. Estimated average percentage change (EAPC) was used to quantify the trends of the age-standardized incidence and mortality rates (ASIR and ASMR, respectively) of EC from 1990 to 2019. Globally, the ASIR of EC significantly increased by 0.69% (95% confidence interval [CI] 0.57-0.81%) per year between 1990 and 2019. This increasing trend was also observed in 160 countries or territories, regardless of the sociodemographic status. The most pronounced increase was found in Italy (EAPC = 4.81, 95% CI, 4.10-5.53), followed by Saudi Arabia and Singapore. Between 1990 and 2019, the ASMR of EC decreased significantly worldwide (EAPC = -0.85, 95% CI, -0.93 to -0.76) but increased significantly in 91 countries or territories, with the highest increase in Lesotho (EAPC = 3.27, 95% CI, 2.81-3.74). The ASMR-ASIR ratio of EC was higher in developing countries than in developed countries. This ratio showed a decreasing trend at the national level over the past three decades. EC incidence has ubiquitously increased worldwide. EC mortality has decreased at the global level but increased in many countries. More efforts are required to alleviate the disease burden of EC.

2021-01-04

Ovarian conservation for young women with early-stage, low-grade endometrial cancer: a 2-step schema

In 2020, endometrial cancer continues to be the most common gynecologic malignancy in the United States. The majority of endometrial cancer is low grade, and nearly 1 of every 8 low-grade endometrial cancer diagnoses occurs in women younger than 50 years with early-stage disease. The incidence of early-stage, low-grade endometrial cancer is increasing particularly among women in their 30s. Women with early-stage, low-grade endometrial cancer generally have a favorable prognosis, and hysterectomy-based surgical treatment alone can often be curative. In young women with endometrial cancer, consideration of ovarian conservation is especially relevant to avoid both the short-term and long-term sequelae of surgical menopause including menopausal symptoms, cardiovascular disease, metabolic disease, and osteoporosis. Although disadvantages of ovarian conservation include failure to remove ovarian micrometastasis (0.4%-0.8%), gross ovarian metastatic disease (4.2%), or synchronous ovarian cancer (3%-5%) at the time of surgery and the risk of future potential metachronous ovarian cancer (1.2%), ovarian conservation is not negatively associated with endometrial cancer-related or all-cause mortality in young women with early-stage, low-grade endometrial cancer. Despite this, utilization of ovarian conservation for young women with early-stage, low-grade endometrial cancer remains modest with only a gradual increase in uptake in the United States. We propose a framework and strategic approach to identify young women with early-stage, low-grade endometrial cancer who may be candidates for ovarian conservation. This evidence-based schema consists of a 2-step assessment at both the preoperative and intraoperative stages that can be universally integrated into practice.

2020-09-30

Microscale endometrial sampling biopsy in detecting endometrial cancer and atypical hyperplasia in a population of 1551 women: a comparative study with hysteroscopic endometrial biopsy

Abstract Background Endometrial cancer is one of the most common malignancies of the reproductive system. Effective and cost-effective screening method for populations at high risk is not available. This study aimed to investigate specimen adequacy and the influencing factors in microscale endometrial sampling biopsy and to evaluate the diagnostic accuracy and medical cost of biopsy in endometrial cancer and atypical hyperplasia screenings in comparison with hysteroscopic endometrial biopsy. Methods A total of 1551 patients at high risk for endometrial lesions who required hysteroscopic endometrial biopsy from November 2017 to August 2018 were included. Microscale endometrial sampling biopsy was performed, followed by hysteroscopic endometrial biopsy. We evaluated the specimen adequacy and influencing factors of microscale endometrial sampling. Diagnostic consistency between microscale endometrial sampling biopsy and hysteroscopic endometrial biopsy was evaluated. The sensitivity, specificity, positive predictive value, and negative predictive value of microscale endometrial sampling biopsy in screening for endometrial cancer and atypical hyperplasia were analyzed, and the medical costs of the two procedures were compared. Results The specimen adequacy was 81.2%. Patient age, menopausal status, endometrial thickness, and endometrial lesion type were correlated with specimen adequacy. There was good consistency in distinguishing benign and malignant endometrial diseases between microscale endometrial sampling biopsy and hysteroscopic biopsy (kappa 0.950, 95% CI 0.925–0.975). The sensitivity, specificity, positive predictive value, and negative predictive value of microscale endometrial sampling biopsy were 91.7%, 100.0%, 100.0%, and 99.3% for endometrial cancer screening, respectively, and 82.0%, 100.0%, 100.0%, and 99.4% for atypical hyperplasia screening. The medical cost of endometrial sampling biopsy was only 22.1% of the cost of hysteroscopic biopsy. Conclusions Microscale endometrial sampling biopsy is a minimally invasive alternative technique for obtaining adequate endometrial specimens for histopathological examination. It has the potential to be used in detecting endometrial cancer and atypical hyperplasia with high efficiency and low cost.

Linked Investigators

Koji Matsuo