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

Investigating the association between endometrial cystic spaces, endometrial hyperplasia and endometrial cancer in women with abnormal bleeding

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000627853
Enrollment
792
Registered
2021-05-25
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine if there is any association between endometrial cystic spaces identified on ultrasound and the incidence of endometrial hyperplasia (abnormal uterine cell growth that may or may not become cancerous), and the incidence endometrial cancer in women with abnormal uterine bleeding. Who is it for? You may be eligible for this study if you are aged 30 or older, have been diagnosed with abnormal uterine bleeding and you have been referred to the Royal Women's Hospital (Melbourne) for a hysteroscopy dilatation and curettage (HDC) procedure, or an endometrial biopsy. Study details All participants who choose to enrol in this study will be asked to complete a 15 minute online health questionnaire, and undergo a transvaginal pelvic ultrasound to determine the presence or absence of endometrial cysts. The ultrasound scan will be performed or directly supervised by a senior ultrasound specialist. Where possible this visit will be timed to occur on the same day as the hysteroscopy to avoid a further trip to hospital. It is hoped this research may improve health outcomes by allowing for early identification of endometrial hyperplasia or cancer, which could have additional positive impacts on the future management of women with endometrial cysts.

Interventions

This study looks at the association between endometrial cystic spaces found on ultrasound in women with abnormal uterine bleeding and either endometrial hyperplasia or endometrial cancer. The consenting participants will answer a short (15 minute) online health questionnaire and undergo a transvaginal pelvic ultrasound (30 minutes) to determine the presence or absence of endometrial cysts. The scan will be performed or directly supervised by a senior O&G ultrasound specialist. Where possible th

This study looks at the association between endometrial cystic spaces found on ultrasound in women with abnormal uterine bleeding and either endometrial hyperplasia or endometrial cancer. The consenting participants will answer a short (15 minute) online health questionnaire and undergo a transvaginal pelvic ultrasound (30 minutes) to determine the presence or absence of endometrial cysts. The scan will be performed or directly supervised by a senior O&G ultrasound specialist. Where possible this will be timed to occur on the same day as their endometrial sampling to avoid a further trip to hospital. Participants will then have endometrial sampling (hysteroscopy dilatation and curettage) which is routinely a day procedure.

Sponsors

The Royal Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026