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Trial registered on ANZCTR


Registration number
ACTRN12622000987763
Ethics application status
Approved
Date submitted
20/06/2022
Date registered
13/07/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
13/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Establishment of the National Endometriosis Clinical and Scientific Trials (NECST) Registry to study the life course and impact on quality of life of people living with endometriosis.
Scientific title
Establishment of the National Endometriosis Clinical and Scientific Trials (NECST) Network Registry
Secondary ID [1] 304681 0
None
Universal Trial Number (UTN)
Trial acronym
NECST Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 322653 0
Adenomyosis 322654 0
Benign gynaecology 322656 0
Chronic pelvic pain 322657 0
Abnormal uterine bleeding 322658 0
Fertility 322659 0
Persistent pelvic pain 326798 0
Condition category
Condition code
Reproductive Health and Childbirth 320271 320271 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 320272 320272 0 0
Menstruation and menopause
Reproductive Health and Childbirth 324013 324013 0 0
Fertility including in vitro fertilisation
Public Health 324015 324015 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The NECST Registry aims to collect prospective and longitudinal health data to understand the causes and life course of endometriosis, improve diagnosis and treatment outcomes, and reduce the burden of disease for patients with endometriosis-related symptoms or diagnosed with endometriosis.

Eligible women will be invited to participate by a clinician at a participating site during their appointment (either face-to-face or telehealth).

Interested and consenting women will be asked to complete the following questionnaires (online):
At baseline (duration of questionnaires: 25 - 35 mins)
1. Consent and demographics
2. Clinical presentation and medical history
3. Patient-reported outcome measures (PROMs; and are validated tools)
3a. Euroqol (EQ)-5D-5L (general quality of life questionnaire) and/or
3b. Endometriosis Health Profile (EHP)-30 (endometriosis-specific questionnaire and for women with this diagnosis)
Follow up questionnaires (at time points: 6 months, 12 months and annually thereafter; duration of questionnaires: 10 - 15 mins)
4a. Clinical presentation and medical history (short version) and
4b. EQ-5D and/or
4c. EHP-30

Participating women will be followed up until
1. participant withdraws from the study or
2. participant is lost to follow up or
3. funding to maintain the NECST Registry is discontinued.

Clinicians will be requested to enter data, dependent on the management and treatment plan for the woman. Data collected are under the following modules:
1. Clinical presentation - Diagnosis (mandatory module to be completed)
2. Imaging (including report)
3. Medical treatment
4. Surgical treatment
5. Histopathology (including report)
- Clinicians will upload or enter data into the registry when an imaging scan is performed, there is a change to the medical treatment plan or when surgery is indicated for each participant they care for until
1. participant withdraws from the study or
2. participant is lost to follow up or
3. funding to maintain the NECST Registry is discontinued.
Intervention code [1] 321054 0
Diagnosis / Prognosis
Intervention code [2] 321055 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331753 0
Overall quality of life assessed using the EQ-5D questionnaire.
Timepoint [1] 331753 0
At the time of enrolment, 6 months, 12 months and then annually
Primary outcome [2] 331755 0
Overall quality of life assessed using the EHP-30 questionnaire.
Timepoint [2] 331755 0
At the time of enrolment, 6 months, 12 months and then annually
Primary outcome [3] 331806 0
Incidence of other conditions including adenomyosis or symptoms-related to endometriosis assessed by the clinician or completion of our "Clinical Presentation and Medical History - Follow up" questionnaire
Timepoint [3] 331806 0
At 6 months, 12 months and then annually
Secondary outcome [1] 411026 0
i. Environmental and lifestyle risk factors (composite) - to understand the effects that the environment, our lifestyle and behaviours have on endometriosis and/or adenomyosis; data will be collected to assess this outcome using a study-specific questionnaire completed by the participant.
Timepoint [1] 411026 0
At time of enrolment or at 6 months.
Secondary outcome [2] 411027 0
ii. Detection of endometriosis and/or adenomyosis by imaging methods (including ultrasound or MRI; reports will be uploaded by the clinical research team)
Timepoint [2] 411027 0
Assessed at time of enrolment
Secondary outcome [3] 411028 0
iii. Proportion of participants using hormonal medications (using study-specific questionnaire and data entered by the clinical research team)
Timepoint [3] 411028 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [4] 411667 0
iv. Proportion of participants using pain medications (using study-specific questionnaire and data entered by the clinical research team)
Timepoint [4] 411667 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [5] 411668 0
v. Proportion of patients using other types of medications (using study-specific questionnaire and data entered by the clinical research team)
Timepoint [5] 411668 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [6] 411669 0
vi. Proportion of patients utilising allied health and complementary therapies (using study-specific questionnaire and data entered by the clinical research team)
Timepoint [6] 411669 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [7] 411670 0
vii. Proportion of patients undergoing surgery for the management of endometriosis (data entered/uploaded by the clinical research team)
Timepoint [7] 411670 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [8] 411671 0
viii. Incidence of additional conditions (e.g. fibroids, adenomyosis etc.) identified during surgical management for endometriosis (data entered/uploaded by the clinical research team)
Timepoint [8] 411671 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [9] 411672 0
ix. Incidence of post-surgical complications assessed by the Clavien-Dindo classification (data entered/uploaded by the clinical research team)
Timepoint [9] 411672 0
Assessed at time of enrolment, 6 months, 12 months and annually
Secondary outcome [10] 411673 0
x. Incidence of adverse events experienced by patients using medications for their endometriosis-symptoms (using study-specific questionnaire and data entered by the clinical research team)
Timepoint [10] 411673 0
Assessed at time of enrolment, 6 months, 12 months and annually

Eligibility
Key inclusion criteria
• Have had surgery which has confirmed that you have endometriosis or adenomyosis
• Have any of the below symptoms that might be caused by endometriosis:
- 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 foreseeable 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
Both
Statistical methods / analysis
In our baseline publication and regular statistical report reporting the epidemiological and clinical characteristics of women enrolled on the Registry, all data will be analysed and presented as de-identified, grouped data. Descriptive statistics such as means, standard deviations, medians, inter-quartile ranges (for the continuous variables) and frequency (for the categorical variables) will be used. Cross tabulations and relevant statistical tests (e.g. chi squared) may be performed to describe demographic characteristics associated with an endometriosis 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 e.g. using postcode level data against key characteristics. Geographical data and related classifications will use area levels 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2500
Accrual to date
1353
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 22499 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 22500 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 22501 0
St George Hospital - Kogarah
Recruitment hospital [4] 22503 0
The Royal Women's Hospital - Parkville
Recruitment hospital [5] 22595 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [6] 22617 0
Westmead Hospital - Westmead
Recruitment hospital [7] 25332 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [8] 25333 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [9] 25334 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [10] 25335 0
Epworth Richmond - Richmond
Recruitment hospital [11] 25336 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [12] 25337 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 37734 0
2031 - Randwick
Recruitment postcode(s) [2] 37882 0
2145 - Westmead
Recruitment postcode(s) [3] 37735 0
2217 - Kogarah
Recruitment postcode(s) [4] 37736 0
3052 - Parkville
Recruitment postcode(s) [5] 41039 0
3121 - Richmond
Recruitment postcode(s) [6] 41038 0
3165 - East Bentleigh
Recruitment postcode(s) [7] 41036 0
3168 - Clayton
Recruitment postcode(s) [8] 41037 0
3175 - Dandenong
Recruitment postcode(s) [9] 37850 0
5006 - North Adelaide
Recruitment postcode(s) [10] 41041 0
5092 - Modbury
Recruitment postcode(s) [11] 41040 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 309049 0
Government body
Name [1] 309049 0
Australian Department of Health; Medical Research Future Fund (MRFF)
Country [1] 309049 0
Australia
Primary sponsor type
University
Name
UNSW
Address
School of Clinical Medicine
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 313028 0
None
Name [1] 313028 0
Address [1] 313028 0
Country [1] 313028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308925 0
Monash Health
Ethics committee address [1] 308925 0
Research Support Services
Level 2, I Block
Monash Medical Centre
246 Clayton Rd
Clayton Victoria 3168
Ethics committee country [1] 308925 0
Australia
Date submitted for ethics approval [1] 308925 0
Approval date [1] 308925 0
03/08/2020
Ethics approval number [1] 308925 0
HREC/62508/MonH-2020-226108

Summary
Brief summary
The project is part of a national collaborative project by Australian clinicians and researchers, the National Endometriosis Clinical and Scientific Trials (NECST) Network.

The NECST Registry will be a national resource of participant data that will facilitate high quality research aiming to understand the causes of endometriosis, improve diagnosis and treatment outcomes, and reduce the burden of disease for patients with endometriosis-related symptoms or diagnosed with endometriosis. Currently, there is a lack of clinical data about endometriosis. This is why there can be a delay of 7 – 12 years before a diagnosis of endometriosis is made for some people. In addition, clear care management plans are not yet available due to the lack of understanding of how endometriosis develops or changes during a woman’s lifetime.

The NECST Registry will collect and securely store demographic and health related information from consenting participants, who experience and/or seek management for endometriosis and/or endometriosis-related symptoms or conditions (e,g., adenomyosis).
Trial website
https://www.necstnetwork.org.au
Trial related presentations / publications
Ng, C. H. M., Michelmore, A. G., Mishra, G. D., Montgomery, G. W., Rogers, P. A., & Abbott, J. A. (2023). Establishing the Australian National Endometriosis Clinical and Scientific Trials (NECST) Registry: a protocol paper, Reproduction and Fertility, 4(2), e230014.
Public notes

Contacts
Principal investigator
Name 112362 0
Prof Jason Abbott
Address 112362 0
School of Clinical Medicine, UNSW
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
Country 112362 0
Australia
Phone 112362 0
+61 2 9382 6733
Fax 112362 0
Email 112362 0
j.abbott@unsw.edu.au
Contact person for public queries
Name 112363 0
Dr Cecilia Ng
Address 112363 0
School of Clinical Medicine, UNSW
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
Country 112363 0
Australia
Phone 112363 0
+61 416 807 183
Fax 112363 0
Email 112363 0
cecilia.ng@unsw.edu.au
Contact person for scientific queries
Name 112364 0
Prof Jason Abbott
Address 112364 0
School of Clinical Medicine, UNSW
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
Country 112364 0
Australia
Phone 112364 0
+61 2 9382 6733
Fax 112364 0
Email 112364 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?
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 data currently determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose and subject to approval by Principal Investigator and Data Custodian
How or where can data be obtained?
Access subject to approvals by Principal Investigator and Data Custodian. For queries, please email: cecilia.ng@unsw.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16325Study protocolNg, C. H. M., Michelmore, A. G., Mishra, G. D., Montgomery, G. W., Rogers, P. A., & Abbott, J. A. (2023). Establishing the Australian National Endometriosis Clinical and Scientific Trials (NECST) Registry: a protocol paper, Reproduction and Fertility, 4(2), e230014.https://doi.org/10.1530/RAF-23-0014  382326-(Uploaded-06-06-2022-19-54-06)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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