The association between endometrial cystic spaces in women with abnormal bleeding and endometrial hyperplasia and endometrial cancer

Not Applicable

• Conditions: Endometrial cysts; Endometrial hyperplasia; Endometrial cancer; Cancer - Womb (Uterine or endometrial cancer); Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12621000627853
• Lead Sponsor: The Royal Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 792

Inclusion Criteria

• Women aged 30 years old and above
• With abnormal uterine bleeding
o Defined by any of the following: Postmenopausal bleeding
Intermenstrual bleeding
Postcoital bleeding with a normal cervical screening test (CST) Bleeding less than every 22 days
Heavy or prolonged bleeding
• And waitlisted for HDC or endometrial biopsy for investigation of abnormal uterine bleeding

Exclusion Criteria

• Inability to consent: no capacity or does not fully comprehend consent information
• Known current or previous history of endometrial hyperplasia or endometrial cancer
• Endometrial sampling or intrauterine manipulation performed less than 28 days prior to
recruitment (due to potential alteration of endometrium and impact on subsequent ultrasound
findings)
• Non english speaking background

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of endometrial hyperplasia with or without atypia and endometrial cancer, assessed by endometrial sampling, in women with abnormal uterine bleeding and endometrial cystic spaces on ultrasound [Endometrial sampling will be undertaken within 7 days of pelvic ultrasound];The prevalence of endometrial cystic spaces in women with abnormal uterine bleeding will be assessed by pelvic ultrasound[Diagnosed at the time of ultrasound]

Secondary Outcome Measures

Name	Time	Method
Potential risk factors for endometrial cysts will be identified through study-specific health questionnaire[Health questionnaire performed at time of recruitment]