Endometrial Cancer Screening in High-risk Populations

November 5, 2023 updated by: Wang Jianliu, Peking University People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

22000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high risk population
The enrolled patients underwent simultaneous transvaginal ultrasound examination and microscale endometrial sampling biopsy.
Diagnostic test: transvaginal ultrasound and microscale endometrial sampling biopsy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity
Time Frame: 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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost-effectiveness analysis
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Jianliu Wang, doctor, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endometrial cancer screening

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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