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An Observational Study Based on Endometrial Cancer Risk Screening Model

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05634798
Collaborator
(none)
2,000
Enrollment
1
Location
12
Anticipated Duration (Months)
166.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Study Based on Endometrial Cancer Risk Screening Model
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Obtained endometrial pathological specimens due to any factors [1 year]

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

  2. No endometrial cancer or precancerous lesions [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05634798
Other Study ID Numbers:
  • ZS-3525
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometrial Neoplasms

Study Results

No Results Posted as of Dec 2, 2022