An Observational Study Based on Endometrial Cancer Risk Screening Model

Endometrial Neoplasms Clinical Trial

Official title:

An Observational Study Based on Endometrial Cancer Risk Screening Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634798
• Other study ID #: ZS-3525
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2022
• Source: Peking Union Medical College Hospital
• Contact: Shu Wang, Doctor
• Phone: 008613671246680
• Email: wangshu219[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Other:
• no intervention
There is no intervention in this study.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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