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DEFINITIONS
Trial Review
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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.
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Scientific title
Establishment of the National Endometriosis Clinical and Scientific Trials (NECST) Network Registry
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Secondary ID [1]
304681
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None
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Universal Trial Number (UTN)
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Trial acronym
NECST Registry
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
322653
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Adenomyosis
322654
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Benign gynaecology
322656
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Chronic pelvic pain
322657
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Abnormal uterine bleeding
322658
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Fertility
322659
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Persistent pelvic pain
326798
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Condition category
Condition code
Reproductive Health and Childbirth
320271
320271
0
0
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
320272
320272
0
0
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Menstruation and menopause
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Reproductive Health and Childbirth
324013
324013
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0
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Fertility including in vitro fertilisation
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Public Health
324015
324015
0
0
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Epidemiology
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
5
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Target follow-up type
Years
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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.
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Intervention code [1]
321054
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Diagnosis / Prognosis
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Intervention code [2]
321055
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Early Detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Overall quality of life assessed using the EQ-5D questionnaire.
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Assessment method [1]
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Timepoint [1]
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At the time of enrolment, 6 months, 12 months and then annually
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Primary outcome [2]
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Overall quality of life assessed using the EHP-30 questionnaire.
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Assessment method [2]
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Timepoint [2]
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At the time of enrolment, 6 months, 12 months and then annually
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Primary outcome [3]
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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
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Assessment method [3]
331806
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Timepoint [3]
331806
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At 6 months, 12 months and then annually
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Secondary outcome [1]
411026
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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.
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Assessment method [1]
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Timepoint [1]
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At time of enrolment or at 6 months.
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Secondary outcome [2]
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ii. Detection of endometriosis and/or adenomyosis by imaging methods (including ultrasound or MRI; reports will be uploaded by the clinical research team)
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Assessment method [2]
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Timepoint [2]
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Assessed at time of enrolment
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Secondary outcome [3]
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iii. Proportion of participants using hormonal medications (using study-specific questionnaire and data entered by the clinical research team)
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Assessment method [3]
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Timepoint [3]
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Assessed at time of enrolment, 6 months, 12 months and annually
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Secondary outcome [4]
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iv. Proportion of participants using pain medications (using study-specific questionnaire and data entered by the clinical research team)
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Assessment method [4]
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Timepoint [4]
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Assessed at time of enrolment, 6 months, 12 months and annually
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Secondary outcome [5]
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v. Proportion of patients using other types of medications (using study-specific questionnaire and data entered by the clinical research team)
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Assessment method [5]
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Timepoint [5]
411668
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Assessed at time of enrolment, 6 months, 12 months and annually
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Secondary outcome [6]
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vi. Proportion of patients utilising allied health and complementary therapies (using study-specific questionnaire and data entered by the clinical research team)
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Assessment method [6]
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Timepoint [6]
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Assessed at time of enrolment, 6 months, 12 months and annually
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Secondary outcome [7]
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vii. Proportion of patients undergoing surgery for the management of endometriosis (data entered/uploaded by the clinical research team)
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Assessment method [7]
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Timepoint [7]
411670
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Assessed at time of enrolment, 6 months, 12 months and annually
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Secondary outcome [8]
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viii. Incidence of additional conditions (e.g. fibroids, adenomyosis etc.) identified during surgical management for endometriosis (data entered/uploaded by the clinical research team)
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Assessment method [8]
411671
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Timepoint [8]
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Assessed at time of enrolment, 6 months, 12 months and annually
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Secondary outcome [9]
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ix. Incidence of post-surgical complications assessed by the Clavien-Dindo classification (data entered/uploaded by the clinical research team)
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Assessment method [9]
411672
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Timepoint [9]
411672
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Assessed at time of enrolment, 6 months, 12 months and annually
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Secondary outcome [10]
411673
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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)
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Assessment method [10]
411673
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Timepoint [10]
411673
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Assessed at time of enrolment, 6 months, 12 months and annually
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
8/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
2500
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Accrual to date
1353
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
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Recruitment hospital [1]
22499
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Royal Hospital for Women - Randwick
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Recruitment hospital [2]
22500
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Prince of Wales Private Hospital - Randwick
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Recruitment hospital [3]
22501
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St George Hospital - Kogarah
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Recruitment hospital [4]
22503
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The Royal Women's Hospital - Parkville
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Recruitment hospital [5]
22595
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [6]
22617
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Westmead Hospital - Westmead
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Recruitment hospital [7]
25332
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [8]
25333
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Dandenong Hospital- Monash Health - Dandenong
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Recruitment hospital [9]
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Monash Medical Centre - Moorabbin campus - East Bentleigh
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Recruitment hospital [10]
25335
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Epworth Richmond - Richmond
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Recruitment hospital [11]
25336
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [12]
25337
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Modbury Hospital - Modbury
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Recruitment postcode(s) [1]
37734
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2031 - Randwick
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Recruitment postcode(s) [2]
37735
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2217 - Kogarah
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Recruitment postcode(s) [3]
37736
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3052 - Parkville
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Recruitment postcode(s) [4]
37850
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5006 - North Adelaide
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Recruitment postcode(s) [5]
37882
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2145 - Westmead
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Recruitment postcode(s) [6]
41036
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3168 - Clayton
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Recruitment postcode(s) [7]
41037
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3175 - Dandenong
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Recruitment postcode(s) [8]
41038
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3165 - East Bentleigh
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Recruitment postcode(s) [9]
41039
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3121 - Richmond
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Recruitment postcode(s) [10]
41040
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5112 - Elizabeth Vale
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Recruitment postcode(s) [11]
41041
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5092 - Modbury
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Department of Health; Medical Research Future Fund (MRFF)
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Address [1]
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Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
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Country [1]
309049
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Australia
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Primary sponsor type
University
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Name
UNSW
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Address
School of Clinical Medicine
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
313028
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Country [1]
313028
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308925
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Monash Health
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Ethics committee address [1]
308925
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Research Support Services
Level 2, I Block
Monash Medical Centre
246 Clayton Rd
Clayton Victoria 3168
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Ethics committee country [1]
308925
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Australia
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Date submitted for ethics approval [1]
308925
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Approval date [1]
308925
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03/08/2020
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Ethics approval number [1]
308925
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HREC/62508/MonH-2020-226108
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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).
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Trial website
https://www.necstnetwork.org.au
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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.
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Public notes
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Contacts
Principal investigator
Name
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Prof Jason Abbott
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Address
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School of Clinical Medicine, UNSW
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
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Country
112362
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Australia
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Phone
112362
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+61 2 9382 6733
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Fax
112362
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Email
112362
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[email protected]
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Contact person for public queries
Name
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Dr Cecilia Ng
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Address
112363
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School of Clinical Medicine, UNSW
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
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Country
112363
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Australia
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Phone
112363
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+61 416 807 183
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Fax
112363
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Email
112363
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[email protected]
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Contact person for scientific queries
Name
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Prof Jason Abbott
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Address
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School of Clinical Medicine, UNSW
Royal Hospital for Women
Level 1, Barker Street
Randwick NSW 2031
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Country
112364
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Australia
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Phone
112364
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+61 2 9382 6733
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Fax
112364
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Email
112364
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results only
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When will data be available (start and end dates)?
Data available after publication of main results; no end data currently determined.
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
Any purpose and subject to approval by Principal Investigator and Data Custodian
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How or where can data be obtained?
Access subject to approvals by Principal Investigator and Data Custodian. For queries, please email:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16325
Study protocol
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.
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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF