ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621001579886

Ethics application status

Approved

Date submitted

5/09/2020

Date registered

18/11/2021

Date last updated

18/11/2021

Date data sharing statement initially provided

18/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Can a test be developed based on a biopsy of a woman's womb lining, that helps predict whether or not she has endometriosis?
A prospective case-control study of B-cell lymphoma 6 protein (BCL6), amongst women who are undertaking keyhole surgery.

Scientific title

B-cell lymphoma 6 protein (BCL6) as a potential biomarker for endometriosis: can it be used to predict endometriosis' presence and/or severity?

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1257-7253

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Endometriosis

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Women who fulfil the selection criteria will be invited to participate in the study. Many of these women will already be planned to undertake a concurrent endometrial biopsy (which takes approximately 5 minutes), at the time of their laparoscopy (which may take anything from 30 minutes to 4 hours). If not: we will talk them through a consent form for endometrial biopsy, using the standard dilatation and curettage method. If they agree to participate, their procedure will be booked to occur during the luteal phase of their menstrual cycle (i.e. the two weeks leading up to an expected period).
Patients will be asked to complete an online version of the long-form EHP-30 questionnaire pre-operatively. The EHP-30 is a reliable, validated instrument to measure the health-related quality of life of women with endometriosis. It asks participants (over the course of 30 questions) to recall how often in the last four weeks they have experienced various symptoms of endometriosis. The ‘long-form’ version includes six additional sections (using 23 questions) covering areas such as: work; relationships with children; sexual relationship(s); and feelings about the medical profession, treatment, and infertility.
At their planned procedure, endometrial biopsy will be taken, using the standard dilatation and curettage method. The endometrial biopsy sample will be sent to the laboratory for analysis of the BCL6 level. Laparoscopy will be undertaken (as planned) by trained gynaecologists, and the patient’s endometriosis (if present) will be scored. Clinicians will use the best-known, and most widely used, classification system for endometriosis: the revised American Society for Reproductive Medicine (r-ASRM) classification system. This involves documenting and scoring patients’ endometriotic implants (seen at laparoscopy) based on their location and size, the location and thickness of any adhesions (internal scarring), plus the extent to which the ‘Pouch of Douglas’ (the area between the uterus and bowel) is involved. Patients will then end up being classified as having either: no endometriosis; stage I (minimal); stage II (mild); stage III (moderate); or stage IV (severe) endometriosis.
Operation notes will be accessed as needed, to ensure adherence to the interventions.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Early detection / Screening

Comparator / control treatment

The control group will be made up of women who have laparoscopic surgery, and are not found to have any endometriosis during the procedure.
The control group will undertake the same interventions (endometrial biopsy). Like the cases, they will already be planning to undertake laparoscopic (keyhole) surgery, whether or not they participate in this research.

Control group

Active

Outcomes

Primary outcome [1]

To evaluate BCL6 expression in luteal phase endometrial biopsy in women with and without endometriosis at laparoscopy.

Timepoint [1]

On the day of their planned laparoscopic (keyhole) surgery; in the luteal phase of the participants' menstrual cycle.

Secondary outcome [1]

Health-related quality of life assessed by the Endometriosis Health Profile Questionnaire (EHP-30) long-form

Timepoint [1]

Participants will complete an EHP-30 questionnaire on the day of their laparoscopic (keyhole) surgery.

Secondary outcome [2]

Severity of endometriosis assessed by the r-ASRM classification conducted during the laparascopic procedure

Timepoint [2]

Participants will have their endometriosis assessed and classified on the day of their laparoscopic (keyhole) surgery.

Eligibility

Key inclusion criteria

- Women aged between 18 – 50yo
- Women who have a regular menstrual cycle (i.e. menstrual cycle length 21 - 35 days inclusive)
- Women who are already planning to undertake laparoscopy, for any indication
- English speaking
- Capacity and willingness to give written informed consent
- Willingness to comply with the study
- Willingness to have their planned procedure undertaken in the luteal phase of their menstrual cycle

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

- Women aged < 18yo or > 50yo
- Women with an irregular menstrual cycle (i.e. menstrual cycle length < 21 days or > 35 days)
- Women who have an absolute contra-indication to endometrial biopsy, such as viable (ongoing) intra-uterine pregnancy
- Women who have a relative contra-indication to endometrial biopsy, such as: active cervical or uterine infection
- Women in whom undertaking an (otherwise unnecessary) endometrial biopsy may worsen a pre-existing condition (e.g. Asherman’s syndrome, intra-uterine adhesions)

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

N/A

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

N/A

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Case-control study, based on prospectively-collected data.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Regarding participants’ answers to questions in the EHP-30 questionnaire: SurveyMonkey automatically exports data to statistical software SPSS, which will be used to perform the statistical analysis. Participants’ BCL6 levels will be uploaded into the relevant section of the SPSS document used for this research, as will participants’ endometriosis severity (based on the r-ASRM classification system).
Participants’ BCL6 results will be continuous data, with their BCL6 HSCORE ranging from 0 to 4. Participants’ endometriosis severity will be ordinal data, in that all participants will be categorised into one of five distinct groups: no endometriosis; stage I (minimal) endometriosis; stage II (mild) endometriosis; stage III (moderate) endometriosis; or stage IV (severe) endometriosis. It is expected that participants’ BCL6 results by endometriosis severity will be presented in a boxplot.
Receiver-operator characteristic analysis will be performed to assess the usefulness of the biomarker and to find the optimal cut-off score for BLC6 that differentiates best between cases and controls.
Statistical analysis will aim to determine to what extent patients’ BCL6 levels (on luteal phase endometrial biopsy) is predictive of the presence and severity of endometriosis at laparoscopy. Additional analysis will include patients’ EHP-30 results as a predictive variable, to assess if the combination of BCL6 level plus EHP-30 answers improves the predictive value of these two screening tools for endometriosis.
Students t test will be used to compare mean BLC6 levels between cases and controls.
Regarding participants’ EHP-30 questionnaire results: logistic regression analysis and a multi-variable model will enable us to ascertain whether including particular aspects of the long-form EHP-30 improves the predictive value of BCL6 in finding endometriosis at laparoscopy. If any such relationships are found, it is expected that these results could be presented as a nomogram, or classification tree analysis.
The statistical comparisons will be performed using statistical software SPSS (IBM) or similar, with P values < 0.05 considered significant.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

10/01/2022

Actual

Date of last participant enrolment

Anticipated

5/09/2022

Actual

Date of last data collection

Anticipated

7/11/2022

Actual

Sample size

Target

184

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

North Shore Private Hospital - St Leonards

Recruitment hospital [3]

Concord Repatriation Hospital - Concord

Recruitment hospital [4]

Nepean Hospital - Kingswood

Recruitment hospital [5]

Strathfield Private Hospital - Strathfield

Recruitment hospital [6]

Mater Sydney - North Sydney

Recruitment hospital [7]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2065 - St Leonards

Recruitment postcode(s) [2]

2139 - Concord

Recruitment postcode(s) [3]

2747 - Kingswood

Recruitment postcode(s) [4]

2135 - Strathfield

Recruitment postcode(s) [5]

2060 - North Sydney

Recruitment postcode(s) [6]

2050 - Camperdown

Recruitment postcode(s) [7]

3260 - Camperdown

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Douglass Hanly Moir Pathology

Address [1]

14 Giffnock Avenue Macquarie Park, 2113 NSW

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Genea

Address [2]

2/321 Kent St Sydney, 2000 NSW

Country [2]

Australia

Primary sponsor type

Government body

Name

Northern Sydney Local Health District.

Address

Kolling Building
Level 14
10 Westbourne St
St Leonards, 2065
NSW

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Sydney Local Health District

Address [1]

Level 11 KGV Building Missenden Road CAMPERDOWN, 2050 NSW

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Nepean Blue Mountains Local Health District

Address [2]

C/- Nepean Hospital Derby Street PENRITH NSW 2750

Country [2]

Australia

Secondary sponsor category [3]

Hospital

Name [3]

St Vincent's Hospital

Address [3]

390 Victoria Street Darlinghurst, 2010 NSW

Country [3]

Australia

Secondary sponsor category [4]

Hospital

Name [4]

North Shore Private Hospital

Address [4]

Westbourne Street ST LEONARDS, 2065 NSW

Country [4]

Australia

Secondary sponsor category [5]

Hospital

Name [5]

Strathfield Private Hospital

Address [5]

3-5 Everton Road STRATHFIELD, 2135 NSW

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Level 13
Kolling Building
Royal North Shore Hospital
Reserve Road
St Leonards, 2065
NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/09/2020

Approval date [1]

16/12/2020

Ethics approval number [1]

Summary

Brief summary

This study will collect endometrial biopsies from women who are having laparoscopic surgery. During their operation, the presence +/- severity of a condition called 'endometriosis' will be graded. 
We hope to see whether or not there is a correlation between 'BCL6' levels on their endometrial biopsy specimen, with the presence +/- severity of endometriosis at keyhole surgery.

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alison Bryant-Smith

Address

Centre for Advanced Reproductive Endosurgery 408 / 69 Christie St St Leonards, 2065 NSW

Country

Australia

Phone

+61 2 9966 9121

Fax

+61 2 9966 9126

[email protected]

Contact person for public queries

Name

Alison Bryant-Smith

Address

Centre for Advanced Reproductive Endosurgery 408 / 69 Christie St St Leonards, 2065 NSW

Country

Australia

Phone

+61 2 9966 9121

Fax

+61 2 9966 9126

[email protected]

Contact person for scientific queries

Name

Alison Bryant-Smith

Address

Centre for Advanced Reproductive Endosurgery 408 / 69 Christie St St Leonards, 2065 NSW

Country

Australia

Phone

+61 2 9966 9121

Fax

+61 2 9966 9126

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers who request it from the principal investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?

• All data will be de-identified
The following data will be shared for all study participants:
- demographic data (eg. age)
- primary and secondary outcomes for individual patients (EHP-30 score, endometriosis stage, BCL6 result)

What types of analyses could be done with individual participant data?

• Confirmatory statistical analysis; for this study be replicated / vindicated by other research teams.

When can requests for individual participant data be made (start and end dates)?

From:
Data will be available following the completion of the data analysis for this study (approximately September 2022). Data will be retained for fifteen years, as mandated by our local ethics committee.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• By contacting the principal investigator, at [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Attachment
13755	Informed consent form	Study-related document.pdf
13756	Informed consent form	Study-related document.pdf
13757	Ethical approval	Study-related document.pdf
14160	Study protocol	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