Clinical trial NCT06125886: Endometrial Cancer Screening in High-risk Populations
Official title: A Multicenter Clinical Study on Endometrial Cancer Screening in High-risk Populations in China
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Screening
Keywords: cancer screening
endometrial cancer
endometrial atypical hyperplasia
microscale endometrial sampling
transvaginal ultrasound
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 22000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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

Primary outcomes:
measure: sensitivity and specificity
timeFrame: 2 years
Secondary outcomes:
measure: cost-effectiveness analysis
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Jianliu Wang, doctor
role: PRINCIPAL_INVESTIGATOR
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