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Trial registered on ANZCTR


Registration number
ACTRN12623001210662
Ethics application status
Approved
Date submitted
26/07/2023
Date registered
23/11/2023
Date last updated
23/11/2023
Date data sharing statement initially provided
23/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian Endometriosis Clinicians Collaborative (AECC): adenomyosis substudy
Scientific title
The Australian Endometriosis Clinicians Collaborative (AECC): adenomyosis substudy on pelvic pain
Secondary ID [1] 310164 0
Nil
Universal Trial Number (UTN)
Trial acronym
AECC: adenomyosis
Linked study record
ACTRN12622000987763
This record is a sub-study of ACTRN12622000987763, specifically investigating outcomes of patients with adenomyosis on pelvic pain and abnormal uterine bleeding.

Health condition
Health condition(s) or problem(s) studied:
Adenomyosis 330740 0
Condition category
Condition code
Reproductive Health and Childbirth 327585 327585 0 0
Other reproductive health and childbirth disorders
Public Health 328724 328724 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Current standard of care and management (e.g. hysterectomy) for patients with adenomyosis. Participants will be asked to complete online questionnaires at time of consent, related clinical care information (either from medical records or the clinician directly) will be entered onto the NECST Registry. Consenting participants will be followed up at 6-, 12-months and then annually post-enrolment for 5 years.
Intervention code [1] 326562 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335421 0
Pelvic pain assessed using study-specific questionnaire and visual analogue scale (VAS).
Timepoint [1] 335421 0
Assessed at time of enrolment, 6 months, 12 months and annually for 5 years.
Secondary outcome [1] 424468 0
Change in menstrual bleeding patterns (using study-specific questionnaire).
Timepoint [1] 424468 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [2] 424469 0
Change in quality of life assessed using the EQ-5D questionnaire
Timepoint [2] 424469 0
At the time of enrolment, 6 months, 12 months and annually for 5 years.
Secondary outcome [3] 424470 0
Change in quality of life assessed using the EHP-30.
Timepoint [3] 424470 0
At time of enrolment, 6 months, 12 months and annually for 5 years..
Secondary outcome [4] 428696 0
Cost-effectiveness of diagnostic options used to manage patients with adenomyosis, assessed using patient medical records and data linkage to MBS, PBS and hospital admissions data, Comparative (including Chi-square or Fisher's exact test for categorical variables; or t-tests for continuous variables) and predictive modelling analyses (including logistic regression and machine learning algorithms) will be employed.
Timepoint [4] 428696 0
At time of enrolment, 6 months, 12 months, annually for 5 years and up to 10 years prior to time of enrolment.
Secondary outcome [5] 429087 0
Cost-effectiveness of treatment options used to manage patients with adenomyosis, assessed using patient medical records and data linkage to MBS, PBS and hospital admissions data, Comparative (including Chi-square or Fisher's exact test for categorical variables; or t-tests for continuous variables) and predictive modelling analyses (including logistic regression and machine learning algorithms) will be employed.
Timepoint [5] 429087 0
At time of enrolment, 6 months, 12 months, annually for 5 years and up to 10 years prior to time of enrolment.

Eligibility
Key inclusion criteria
• Enrolled into the main study ACTRN12622000987763
• Have had surgery which has confirmed that you have adenomyosis
• Have any of the below symptoms that might be caused by adenomyosis:
- persistent pelvic pains
- problems with falling pregnant
- excessive menstrual bleeding or bleeding between periods
- heavy periods
- pain when urinating
- pain with bowel motions/passing stools
- pain with sex.
• Speak English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women unable to provide informed consent
• Females aged under 18 years of age
• Women who are not resident in Australia or planning to not reside in Australia for the forseeable future
• Women with insufficient English language ability to give informed consent and complete the baseline survey instruments (at this stage, consent materials and survey modules are only available in English)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All data will be analysed and presented as de-identified, group data. Descriptive statistics such as means, standard deviations, medians, inter-quartile ranges (for continuous variables), and frequency (for categorical variables) will be used. Cross tabulations and relevant statistics tests (e.g. chi squared) may be performed to describe demographic characteristics associated with an adenomyosis patient diagnosis, acquisition of surgical and/or medical management. No small cell sizes will be published where they could result in the possible identification of a participant. Geographical data and related classifications will use area levels of appropriate to the number of participants e.g. state, Accessibility/Remoteness Index of Australia (ARIA), Socio-Economic Indexes for Areas (SEIFA), groupings larger than postcode to prevent small cell sizes arising. No individual level data that could identify non-participants e.g. family members will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2030
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 25220 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 25221 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 25222 0
St George Hospital - Kogarah
Recruitment hospital [4] 25223 0
St George Private Hospital - Kogarah
Recruitment hospital [5] 25224 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [6] 25225 0
Modbury Hospital - Modbury
Recruitment hospital [7] 25226 0
Mater Private Hospital Brisbane - South Brisbane
Recruitment hospital [8] 25227 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 25228 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 40891 0
2031 - Randwick
Recruitment postcode(s) [2] 40892 0
2217 - Kogarah
Recruitment postcode(s) [3] 40896 0
3168 - Clayton
Recruitment postcode(s) [4] 40895 0
4101 - South Brisbane
Recruitment postcode(s) [5] 40894 0
5092 - Modbury
Recruitment postcode(s) [6] 40893 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 40897 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 314321 0
Government body
Name [1] 314321 0
Australian Department of Health and Aged Care; Medical Research Future Fund (MRFF)
Country [1] 314321 0
Australia
Primary sponsor type
University
Name
UNSW
Address
School of Clinical Medicine, Faculty of Medicine and HealthDivision of Women's HealthLevel 1, Royal Hospital for WomenBarker StreetRandwick NSW 2031
Country
Australia
Secondary sponsor category [1] 316276 0
None
Name [1] 316276 0
Address [1] 316276 0
Country [1] 316276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313431 0
Monash Health
Ethics committee address [1] 313431 0
Research Support ServicesLevel 2, I BlockMonash Medical Centre246 Clayton RdClayton VIC 3168
Ethics committee country [1] 313431 0
Australia
Date submitted for ethics approval [1] 313431 0
Approval date [1] 313431 0
03/08/2020
Ethics approval number [1] 313431 0
HREC/62508/Mon-H-2020-226108

Summary
Brief summary
Like endometriosis, adenomyosis is a benign uterine disorder and is histologically defined by presence of endometrial tissue in the myometrium (muscle layer) of the uterus. The prevalence of adenomyosis is difficult to determine, since histological confirmation is necessary following surgical biopsy or more commonly hysterectomy. For women wanting to retain their uterus, hysterectomy is not an option. Imaging technologies (e.g. transvaginal ultrasound and MRI), are used as a less invasive method of diagnosis and detection, although they have limitations. The Australian Endometriosis Clinicians Collaborative (AECC): adenomyosis substudy is a prospective longitudinal clinical study that will:
1. compare diagnosis and treatment of adenomyosis with regards to impact on pain, bleeding patterns, general health symptoms and quality of life using validated questionnaires
2. determine cost-effectiveness of diagnostic and treatment options
3. establish a national biobank of adenomyosis (and endometriosis) for future research capacity.
Outcomes will determine optimised diagnosis and treatment pathways for clinicians that improve quality of life for women with adenomyosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128134 0
Prof Jason Abbott
Address 128134 0
School of Clinical Medicine, Faculty of Medicine and HealthDiscipline of Women's Health, UNSW SydneyLevel 1, Royal Hospital for WomenBarker StreetRandwick NSW 2031
Country 128134 0
Australia
Phone 128134 0
+61 293826722
Fax 128134 0
Email 128134 0
j.abbott@unsw.edu.au
Contact person for public queries
Name 128135 0
Dr Cecilia Ng
Address 128135 0
School of Clinical Medicine, Faculty of Medicine and HealthDiscipline of Women's Health, UNSW SydneyLevel 1, Royal Hospital for WomenBarker StreetRandwick NSW 2031
Country 128135 0
Australia
Phone 128135 0
+61 416807183
Fax 128135 0
Email 128135 0
cecilia.ng@unsw.edu.au
Contact person for scientific queries
Name 128136 0
Prof Jason Abbott
Address 128136 0
School of Clinical Medicine, Faculty of Medicine and HealthDiscipline of Women's Health, UNSW SydneyLevel 1, Royal Hospital for WomenBarker StreetRandwick NSW 2031
Country 128136 0
Australia
Phone 128136 0
+61 293826722
Fax 128136 0
Email 128136 0
j.abbott@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
Data available after publication of main results; no end date currently determined.
Available to whom?
To researchers on a case-by-case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
Any purpose and subject to approval by the Principal Investigator.
How or where can data be obtained?
Access subject to approvals by Principal Investigator. Please email cecilia.ng@unsw.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19759Study protocolNg, CHM, Michelmore, AG, Mishra, GD, Montgomery, GW, Rogers, P & Abbott, J 2023. Establishing the Australian National Endometriosis Clinical and Scientific Trials (NECST) Registry: A protocol paper. Reproduction and Fertility, RAF-23-0014.https://doi.org/10.1530/RAF-23-0014cecilia.ng@unsw.edu.au 386269-(Uploaded-26-07-2023-22-26-34)-Study-related document.pdf



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.