Endometrial Lesions Predictions

• Sponsor: Beijing Friendship Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05588076
• Collaborator: (none)
• Enrollment: 900
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 64.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Endometrial Neoplasms	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 900 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
normal endometrial	Other: no intervention; no intervention
endometrial lesions

Outcome Measures

Primary Outcome Measures

1. pathology of endometrial lesions [1 year]

   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.

Secondary Outcome Measures

1. Ultrasonographic Examination [1 year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital	Beijing		China

Sponsors and Collaborators

• Beijing Friendship Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Friendship Hospital
• ClinicalTrials.gov Identifier: NCT05588076
• Other Study ID Numbers: AUBEM
• First Posted: Oct 20, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Oct 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 Oct 20, 2022