An Observational Study Based on Endometrial Cancer Risk Screening Model

NCT05634798 | Unknown

• 1 other identifier: ZS-3525
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Neoplasms

Outcome Measures

Primary Outcomes (2)

• Obtained endometrial pathological specimens due to any factors

  The study object was obtained endometrial pathological specimen within one year due to any factor.

  1 year

• No endometrial cancer or precancerous lesions

  The study object did not show B-ultrasound and clinical symptoms which indicate endometrial cancer or precancerous lesions.

  1 year

Interventions

no intervention OTHER

There is no intervention in this study.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age: 18-70;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shu Wang, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Wang, Doctor

CONTACT

008613671246680; wangshu219@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)