Endometrial Lesions Predictions

Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding

To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB).

Study Overview

• Status: Active, not recruiting
• Conditions: Endometrial Neoplasms
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 900

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This cross-sectional study was approved by the Institutional Ethics Committee and conducted in the Beijing Friendship Hospital, Capital Medical University in China

Description

Inclusion Criteria:

• 1) non-pregnancy related abnormal uttering bleeding（AUB） in women of 18-60 years old; 2)women who had indications for hysteroscopy and endometrial histology in the study period

Exclusion Criteria:

• 1) postmenopausal women, 2) AUB due to other causes such as hormones or medications, coagulation disorders, and vascular malformation of the uterus; 3) final diagnosis outside the scope of this study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal endometrial	Other: no intervention; no intervention
endometrial lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathology of endometrial lesions	Endometrial tissue was curettaged and sent for pathological examination in 10% formalin. A senior pathologist who was not blinded to clinical and ultrasound information examined the samples and determined the final diagnosis. The outcomes of histology are classified as normal endometrium and endometrial lesions, which include 1)endometrial polyps,2)endometrial hyperplasia without atypia, 3)endometrial atypical hyperplasia and 4) endometrial carcinoma.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonographic Examination	VS examinations were performed by an experienced physician with a vaginal probe of 5.5 MHz of a GE VolusonE10 Ultrasound device to look for endometrial thickness and abnormal echoes. Endometrial thickness (ET) was measured at the thickest part with double layers	1 year

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Wenjing Zhang, Dr, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: AUBEM

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