Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000627853p
Ethics application status
Submitted, not yet approved
Date submitted
25/03/2021
Date registered
25/05/2021
Date last updated
25/05/2021
Date data sharing statement initially provided
25/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The association between endometrial cystic spaces in women with abnormal bleeding and endometrial hyperplasia and endometrial cancer
Scientific title
Investigating the association between endometrial cystic spaces, endometrial hyperplasia and endometrial cancer in women with abnormal bleeding
Secondary ID [1] 303793 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial cysts 321300 0
Endometrial hyperplasia 321301 0
Endometrial cancer
 321302 0
Condition category
Condition code
Cancer 319084 319084 0 0
Womb (Uterine or endometrial cancer)
Reproductive Health and Childbirth 319443 319443 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 320096 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326969 0
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
Timepoint [1] 326969 0
Endometrial sampling will be undertaken within 7 days of pelvic ultrasound
Primary outcome [2] 326970 0
The prevalence of endometrial cystic spaces in women with abnormal uterine bleeding will be assessed by pelvic ultrasound
Timepoint [2] 326970 0
Diagnosed at the time of ultrasound
Secondary outcome [1] 393317 0
Potential risk factors for endometrial cysts will be identified through study-specific health questionnaire
Timepoint [1] 393317 0
Health questionnaire performed at time of recruitment

Eligibility
Key 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
Minimum age
30 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

All data will be assessed for normality. Groups will be summarised using mean and standard deviations for continuous variables and proportions (percentages) for categorical variables. Univariable logistic regression will be used to compare variables between participants with and without endometrial cysts, quoting crude odds ratios with 95% confidence intervals. When modelling for risk factors and potential confounders multivariable logistic regression will be performed. Potential confounders include BMI, unopposed oestrogen therapy, polycystic ovarian syndrome, personal history of breast, ovarian or bowel cancer, family history of breast, ovarian or bowel cancer, Lynch syndrome, BRCA mutation, tamoxifen use. Potential risk factors include Age, ethnicity, menopausal status, endometrial ablation, hormonal therapies, parity, type 2 diabetes, gestational diabetes, hypertension, family history of diabetes, heart disease, hypertension or stroke. Exploratory sub analysis will be performed dividing the group on menopausal status.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
792
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19021 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 33565 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 308196 0
Hospital
Name [1] 308196 0
The Royal Women's Hospital
Country [1] 308196 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
20 Flemington Rd Parkville, Vic 3052
Country
Australia
Secondary sponsor category [1] 308975 0
None
Name [1] 308975 0
Address [1] 308975 0
Country [1] 308975 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308177 0
Royal Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 308177 0
20 Flemington Rd
Parkville, Vic
3052
Ethics committee country [1] 308177 0
Australia
Date submitted for ethics approval [1] 308177 0
06/01/2021
Approval date [1] 308177 0
Ethics approval number [1] 308177 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109814 0
Dr Catherine Schepisi
Address 109814 0
Royal Women's Hospital
20 Flemington Rd Parkville, Vic 3052
Country 109814 0
Australia
Phone 109814 0
+61 3 83452000
Fax 109814 0
Email 109814 0
[email protected]
Contact person for public queries
Name 109815 0
Dr Catherine Schepisi
Address 109815 0
Royal Women's Hospital
20 Flemington Rd
Parkville, Vic 3052
Country 109815 0
Australia
Phone 109815 0
+61 3 83452000
Fax 109815 0
Email 109815 0
[email protected]
Contact person for scientific queries
Name 109816 0
Dr Catherine Schepisi
Address 109816 0
Royal Women's Hospital
20 Flemington Rd
Parkville, Vic 3052
Country 109816 0
Australia
Phone 109816 0
+61 3 83452000
Fax 109816 0
Email 109816 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.