Endometrial Lesions Predictions

NCT05588076 | Unknown

• 1 other identifier: AUBEM
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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).

Conditions

Endometrial Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ultrasonographic Examination

  1 year

Study Arms (2)

normal endometrial

Other: no intervention

endometrial lesions

Interventions

no intervention OTHER

no intervention

normal endometrial

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Wenjing Zhang, Dr

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 20, 2022
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)