Endometrial Lesions Predictions

Endometrial Neoplasms Clinical Trial

Official title:

Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05588076
• Other study ID #: AUBEM
• Status: Active, not recruiting
• Start date: October 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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