Endometrial Cancer Screening in High-risk Populations

Trial Title: Endometrial Cancer Screening in High-risk Populations

NCT ID: NCT06125886

Condition: Cancer Screening

Conditions: Official terms:
Endometrial Neoplasms

Conditions: Keywords:
cancer screening
endometrial cancer
endometrial atypical hyperplasia
microscale endometrial sampling
transvaginal ultrasound

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: transvaginal ultrasound and microscale endometrial sampling biopsy
Description: 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.
Arm group label: high risk population

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.

Detailed description: 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 1. 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. 2. 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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 15, 2023

Completion date: December 30, 2025

Lead sponsor:
Agency: Peking University People's Hospital
Agency class: Other

Source: Peking University People's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06125886