Endometrial Cancer Screening in High-risk Populations

Study Overview
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Brief Summary
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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.

Detailed Description
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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. If there is a positive result in either vaginal ultrasound or endometrial microstructural pathological examination, further hysteroscopic staging and scraping of endometrial tissue pathological examination shall be performed. follow-up If the results of transvaginal ultrasound and microscale endometrial sampling biopsy are negative, a follow-up examination of transvaginal ultrasound and microscale endometrial sampling biopsy will be conducted one year later. If a positive result is found on the follow-up examination, further hysteroscopy/segmented curettage of endometrial tissue pathology will be performed. Those who showed negative results on transvaginal ultrasound but failed to obtain endometrial tissue pathology examination (result A): Three months later, they underwent a follow-up examination of transvaginal ultrasound and microscale endometrial sampling biopsy. Those who showed positive results on the follow-up examination were further subjected to hysteroscopy/segmented curettage of endometrial tissue pathology examination.

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

Conditions
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Cancer Screening

Intervention / Treatment
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* Diagnostic Test: transvaginal ultrasound and microscale endometrial sampling biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 45 years old Hypertension Diabetes 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high risk population<br>The enrolled patients underwent simultaneous transvaginal ultrasound examination and microscale endometrial sampling biopsy. | Diagnostic Test: transvaginal ultrasound and microscale endometrial sampling biopsy<br>* Transvaginal ultrasound and endometrial micro tissue pathology examination are used concurrently for endometrial cancer screening in high-risk populations. The specificity, sensitivity, and optimal combination of the two screening methods are clarified, and a cost-effectiveness analysis is conducted on different screening strategy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer screening, endometrial cancer, endometrial atypical hyperplasia, microscale endometrial sampling, transvaginal ultrasound