ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Public Health

Epidemiology

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Pelvic pain assessed using study-specific questionnaire and visual analogue scale (VAS).

Timepoint [1]

Assessed at time of enrolment, 6 months, 12 months and annually for 5 years.

Secondary outcome [1]

Change in menstrual bleeding patterns (using study-specific questionnaire).

Timepoint [1]

Assessed at time of enrolment, 6 months, 12 months and annually

Secondary outcome [2]

Change in quality of life assessed using the EQ-5D questionnaire

Timepoint [2]

At the time of enrolment, 6 months, 12 months and annually for 5 years.

Secondary outcome [3]

Change in quality of life assessed using the EHP-30.

Timepoint [3]

At time of enrolment, 6 months, 12 months and annually for 5 years..

Secondary outcome [4]

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]

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]

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]

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?

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]

Royal Hospital for Women - Randwick

Recruitment hospital [2]

Prince of Wales Private Hospital - Randwick

Recruitment hospital [3]

St George Hospital - Kogarah

Recruitment hospital [4]

St George Private Hospital - Kogarah

Recruitment hospital [5]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [6]

Modbury Hospital - Modbury

Recruitment hospital [7]

Mater Private Hospital Brisbane - South Brisbane

Recruitment hospital [8]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [9]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

2031 - Randwick

Recruitment postcode(s) [2]

2217 - Kogarah

Recruitment postcode(s) [3]

5112 - Elizabeth Vale

Recruitment postcode(s) [4]

5092 - Modbury

Recruitment postcode(s) [5]

4101 - South Brisbane

Recruitment postcode(s) [6]

3168 - Clayton

Recruitment postcode(s) [7]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Department of Health and Aged Care; Medical Research Future Fund (MRFF)

Address [1]

GPO Box 9848Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health

Ethics committee address [1]

Research Support ServicesLevel 2, I BlockMonash Medical Centre246 Clayton RdClayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/08/2020

Ethics approval number [1]

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

Prof Jason Abbott

Address

School of Clinical Medicine, Faculty of Medicine and HealthDiscipline of Women's Health, UNSW SydneyLevel 1, Royal Hospital for WomenBarker StreetRandwick NSW 2031

Country

Australia

Phone

+61 293826722

Fax

[email protected]

Contact person for public queries

Name

Cecilia Ng

Address

School of Clinical Medicine, Faculty of Medicine and HealthDiscipline of Women's Health, UNSW SydneyLevel 1, Royal Hospital for WomenBarker StreetRandwick NSW 2031

Country

Australia

Phone

+61 416807183

Fax

[email protected]

Contact person for scientific queries

Name

Jason Abbott

Address

School of Clinical Medicine, Faculty of Medicine and HealthDiscipline of Women's Health, UNSW SydneyLevel 1, Royal Hospital for WomenBarker StreetRandwick NSW 2031

Country

Australia

Phone

+61 293826722

Fax

[email protected]

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 [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19759	Study protocol	Ng, 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-23-0014	[email protected]		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.

Trial Review

Documents added manually

Documents added automatically