An Observational Study Based on Endometrial Cancer Risk Screening Model

November 22, 2022 updated by: Peking Union Medical College Hospital

The goal of this observational study is to test the efficiency of our endometrial cancer risk screening calculator, and improve the endometrial cancer risk screening model to form a stable and reliable non-invasive auxiliary diagnostic tool with high sensitivity and specificity in healthy women.The main question it aims to answer is:

·the efficiency of our endometrial cancer risk screening calculator Participants will be collected demographic information, as well as ultrasound, blood routine test and other test results, which will be entered into the endometrial cancer risk screening calculator to obtain high-risk or low-risk prediction results.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The subjects were women of childbearing age, perimenopause and postmenopausal who had undergone physical examination in Peking Union Medical College Hospital or were recruited by patients from gynecological clinics.

Description

Inclusion Criteria:

  1. Age: 18-70;
  2. The annual update of questionnaire information required by the calculator can be completed, and the gynecological examination, gynecological B-ultrasound and blood test can be evaluated once a year, and the follow-up can be at least 1 year; The patient or family members can understand the research scheme and are willing to participate in the study, and provide e-book informed consent.

Exclusion Criteria:

  1. Endometrial cancer or precancerous lesions have been diagnosed;
  2. Previous or current malignant tumor, currently receiving radiotherapy and chemotherapy, endocrine, targeted and immunotherapy;
  3. History of endometrial resection or total hysterectomy;
  4. Pregnant or lactating women;
  5. The patient or family member could not understand the conditions and objectives of this study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obtained endometrial pathological specimens due to any factors
Time Frame: 1 year
The study object was obtained endometrial pathological specimen within one year due to any factor.
1 year
No endometrial cancer or precancerous lesions
Time Frame: 1 year
The study object did not show B-ultrasound and clinical symptoms which indicate endometrial cancer or precancerous lesions.
1 year

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Shu Wang, Doctor, Peking Union Medical College Hospital

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 (ANTICIPATED)

December 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (ACTUAL)

December 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-3525

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.

Clinical Trials on Endometrial Neoplasms

Clinical Trials on no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe