None listed
Conditions
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.
Interventions
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 tak
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.
Sponsors
Te Whatu Ora
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Maori, Pacific, non-Maori non-Pacific women undergoing hysterectomy for EC or a non-EC condition
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.
Outcome results
None listed