Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001362684p
Ethics application status
Not yet submitted
Date submitted
14/04/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Endometrial Cancer Microbiome Study
Scientific title
A study to assess the presence of Porphyromonas somrae (P. somerae) present in the endometrial and vaginal microbiome of patients with Endometrial Cancer (EC) in Aotearoa, and that P. somerae and abnormal vaginal pH are indicators of EC in a diverse population of women in Aotearoa NZ.
Secondary ID [1] 309286 0
nil
Universal Trial Number (UTN)
Trial acronym
ECMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 329451 0
Condition category
Condition code
Cancer 326390 326390 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be a prospective, cross-sectional, observational study of 260 patients. A optional blood sample will be taken on the day of surgery by the research nurse. This will consist of 3 10ml tubes and samples will be transferred to the regional biobank within 2 hours or 2 weeks (dependent on blood test tube used). The pre-operative vaginal swabs will be on the day of surgery, in theatre by the surgeon following anaesthesia but before the routine antiseptic wash. Three vaginal swabs will be taken with the first being analysed for pH in theatre by the research nurse. The second two samples will be placed in the buffer and transferred to the central laboratory for processing. Once the hysterectomy is complete the theatre team will contact the research nurse to collect the specimen and this will be taken to the hospital laboratory for processing by the pathologist. A pathologist will review the specimen and where appropriate proceed to take the 2 endometrial swabs and 1-3 endometrial tissue samples. The swabs will be placed in the liquid buffer and transferred with the vaginal swabs to the central laboratory for PCR and microbiome analysis. The endometrial tissue will be snap frozen by the research nurse and delivered to the regional biobank for processing and storage. It is anticipated the time to take the swabs will be 5-10minutes. The time to take the endometrial tissue samples 20-30minutes (this may include opening and assessing the uterus). All swabs will undergo PCR and microbiome analysis. The blood and endometrial tissue samples will be banked for future (unspecified) research. There is no planned follow up of participants.
Intervention code [1] 325870 0
Early Detection / Screening
Comparator / control treatment
women undergoing hysterectomy for non-EC condition
Control group
Active

Outcomes
Primary outcome [1] 334448 0
detection of vaginal P. somerae by PCR testing
Timepoint [1] 334448 0
Tests to be conducted up to 6 months post collection
Secondary outcome [1] 420730 0
presence of vaginal P. somerae and vaginal pH >4.5 using a pH test strip
Timepoint [1] 420730 0
Test to be conducted up to 6 months post collection
Secondary outcome [2] 421255 0
presence of endometrial P. somerae from swabs and PCR testing
Timepoint [2] 421255 0
Test to be conducted up to 6 months post collection
Secondary outcome [3] 421256 0
presence of endometrial P. somerae and vaginal pH >4.5 by swabs and PCR tests
Timepoint [3] 421256 0
Test to be conducted up to 6 months post collection

Eligibility
Key inclusion criteria
Maori, Pacific, non-Maori non-Pacific women undergoing hysterectomy for EC or a non-EC condition
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to consent, pre-operative diagnosis of sarcoma/adenosarcoma, recent antibiotic use or recent pregnancy/birth (within last 4 weeks). pH analysis will not be performed on swabs with visible blood.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For each of the outcomes of interest, the following metrics will
be determined in relation to identification of EC: i) sensitivity; ii) specificity; iii) positive predictive value, iv) negative predictive value for EC; and iv) area under the receiver operating curve. Analyses will be conducted for the total study population, with sub-group analyses by ethnic group, by menopausal status, by BMI, and by diabetes status.
STATA 16.0. will be used for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
9/11/2026
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment outside Australia
Country [1] 25395 0
New Zealand
State/province [1] 25395 0
Auckland

Funding & Sponsors
Funding source category [1] 313481 0
Government body
Name [1] 313481 0
Te Whatu Ora
Country [1] 313481 0
New Zealand
Primary sponsor type
Government body
Name
Te Whatu Ora
Address
74 Taharoto RoadTakapunaAuckland 0622
Country
New Zealand
Secondary sponsor category [1] 315254 0
None
Name [1] 315254 0
Address [1] 315254 0
Country [1] 315254 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312672 0
Health and Disability Ethics Committee
Ethics committee address [1] 312672 0
133 Molesworth StreetThorndonWellington 6011
Ethics committee country [1] 312672 0
New Zealand
Date submitted for ethics approval [1] 312672 0
30/08/2024
Approval date [1] 312672 0
Ethics approval number [1] 312672 0

Summary
Brief summary
Endometrial Cancer (EC; cancer of the uterus or womb) is a significant health and equity issue in Aotearoa. Pacific women have one of the highest incidence rates in the world, and it is rising extremely rapidly, with EC now being the biggest contributor to the life expectancy gap for Pacific women. There are also inequities for Maori women in both EC incidence and mortality. Potential drivers of EC include obesity, diabetes and menopausal status. More recently, studies have indicated links between microbial communities (microbiome) in the endometrium and vaginal and EC. In the US an anaerobic bacteria (bacteria which grows without oxygen), Porphyromonas somerae has been found to be associated with EC. The lead author is working with us to examine whether this bacteria can be detected, alongside changes in pH, on vaginal swabs and endometrial samples in a large and diverse population in Aotearoa; Maori, Pacific and non-Maori non-Pacific women. Our group has significant experience and expertise in designing and delivering equity focused screening programmes. If P. somerae is found to be a biomarker for EC this raises the possibility of a minimally invasive screening test (vaginal self-test) in the future, with the ultimate aim of addressing EC inequities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125510 0
Dr Karen Bartholomew
Address 125510 0
Te Whatu Ora, 74 Taharoto RdTakapuna Auckland 0622
Country 125510 0
New Zealand
Phone 125510 0
+64 212115629
Fax 125510 0
Email 125510 0
[email protected]
Contact person for public queries
Name 125511 0
Dr Karen Bartholomew
Address 125511 0
Te Whatu Ora, 74 Taharoto Rd Takapuna Auckland 0622
Country 125511 0
New Zealand
Phone 125511 0
+64 212115629
Fax 125511 0
Email 125511 0
[email protected]
Contact person for scientific queries
Name 125512 0
Dr Karen Bartholomew
Address 125512 0
Te Whatu Ora, 74 Taharoto Rd Takapuna Auckland 0622
Country 125512 0
New Zealand
Phone 125512 0
+64 212115629
Fax 125512 0
Email 125512 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This research will have a specific data and tissue management plan and be guided by Maori data sovereignty principles and Pacific health data assessments


What supporting documents are/will be available?

No Supporting Document Provided



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.