SONNET
Improving tests for postmenopausal bleeding
The SONNET (Study of Novel Endometrial Cancer Diagnostics) study is focused on improving how we identify people with suspected womb cancer for further testing after experiencing postmenopausal bleeding.
The project is run by The University of Manchester and funded by the National Institute for Health and Care Research (NIHR).
This page outlines the study background, information for participants, details about the research team, and how to get in touch.
On this page:
Background
Why this study is taking place
Bleeding after menopause can sometimes be a sign of womb cancer (also called endometrial cancer), and people with this symptom may be offered several tests. These include:
- an internal (vaginal) ultrasound scan;
- a camera test inside the womb (hysteroscopy);
- and a biopsy of the lining of the womb (endometrium).
Some people find hysteroscopy and biopsy uncomfortable or even painful. The tests can also cause bleeding and infection, and may need to be repeated if they fail. This can be stressful, yet only about five in 100 people who have bleeding after the menopause are diagnosed with womb cancer.
Exploring new approaches
We are exploring new patient-friendly tools to help doctors decide who really needs the tests and who can be safely reassured without them.
The new tools, which have the potential to be performed in more convenient community locations, could help to:
- reduce the number of women undergoing unnecessary invasive tests;
- shorten waiting times;
- and speed up diagnosis for those who do have womb cancer.
Learn about SONNET
Watch this short video to learn what the SONNET study involves, why it matters, and how it could help improve care for people with postmenopausal bleeding.
A written transcript of this video is available:
Information for participants
How we will run the study
This study will look at the accuracy of a new patient-friendly tool, PREDICT-EC. The tool is designed to predict a person’s likelihood of womb cancer. If a person’s risk of womb cancer is high, the tool would indicate further tests such as a hysteroscopy and/or biopsy are needed. If the risk is very low, the tool would indicate that further testing is not needed, and womb cancer can be ruled out.
For the study, participants will be asked to:
- provide a urine sample for testing;
- share information about their symptoms and medical history;
- and complete a questionnaire.
Behind the scenes, we will compare the accuracy of the tool against the current NHS referral pathway. Participants will continue to receive their usual NHS care. Because the tool is still in development, its results will not affect clinical decisions.
We will also look at the cost of the new tool compared to current NHS care, and we will conduct workshops and interviews to understand what patients and experts think of the tool and how well it will work in real life.
In addition to the urine sample, participants also have the option to provide a blood sample and a vaginal swab sample. These samples will help us assess two more risk prediction tools (spectroscopy and WID-easy) and their ability to identify the likelihood of womb cancer. We would like to assess how each tool performs individually and how they work when combined.
Participant Information Sheet (PIS)
Take time to read the Participant Information Sheet (PIS) to understand why the research is being done and what it will involve.
Who will be invited to participate in the study
We will recruit around 3,000 people who have been referred to gynaecology clinics across hospitals in England, Wales and Scotland for investigations of bleeding after the menopause.
It is important that the test works for everyone, so we will look at how well the tools work in people of different ages, ethnicities and backgrounds, as well as people with different types of womb cancer and pre-cancer.
Study locations
- St Mary’s Hospital, Manchester
- Royal Preston Hospital, Preston
Current NHS referral pathway for suspected womb cancer
People with suspected womb cancer will usually have an internal vaginal scan first. The scan helps decide whether further tests, a hysteroscopy and/or biopsy, are needed.
While transvaginal scans are good at referring people with womb cancer for further tests, they are less good at identifying people who do not have womb cancer. This means many people undergo invasive procedures that may not be necessary.
View a flowchart showing the current pathway of recommended investigations:
Tools being assessed in this study
What is it?
Online calculator.
How does it work?
Combines personal information about you:
- Age
- Body weight
- Symptoms
- Hormone tablet use
and results from routine clinical tests:
- Urine dip for blood
- Thickness of womb lining on scan
to generate a score that predicts the chance that you have womb cancer.
What happens next?
The calculator gives an instant result:
- If you have a LOW score, your chance of having womb cancer is so low that you can be safely reassured.
- If you have a HIGH score, more tests are needed to rule out womb cancer as the cause of your symptoms.
At what stage of development is the tool?
We developed the PREDICT-EC algorithm using data from nearly 2000 women who were investigated for postmenopausal bleeding. The tool performed better than transvaginal scan alone for identifying who needed further tests.
With funding from the NIHR, we are now validating the tool in a larger and more diverse population to ensure it works effectively across different settings and patient groups. We will also collaborate with a designer and software developers to co-design and build a clinician-facing digital version of PREDICT-EC (an app) for future use in the NHS.
What is it?
Probe that measures how light scatters from a urine or blood sample.
How does it work?
A special type of light is shone onto your urine or blood sample in clinic. The probe records how the light is scattered by the sample. AI is used to predict the chance that you have womb cancer from the way the light scatters.
What happens next?
The device gives a result in 5-10 minutes. It helps your doctor decide if further tests are needed to rule out womb cancer as the cause of your symptoms.
At what stage of development is the tool?
Currently, spectroscopy is used only in research settings and is not part of routine NHS care. Pilot studies have shown that blood and urine spectroscopy can accurately detect endometrial cancer.
To make this technology even better, we are partnering with Lancashire Teaching Hospitals and NSV Inc. to design and develop a portable device that could be used at the point of care within the NHS in the future.
What is it?
Laboratory test for genetic changes in a vaginal swab sample.
How does it work?
The swab is sent to a laboratory to be tested by PCR (a similar technique is used for the COVID-19 test). The test measures changes to the DNA in your swab sample that are linked to womb cancer. The pattern of changes seen is used to predict the chance that you have womb cancer.
What happens next?
The results take three or more days to come back. They help your doctor decide if further tests are needed to rule out womb cancer as the cause of your symptoms.
At what stage of development is the tool?
The WID®-easy test has already been developed and validated in previous research. It has demonstrated excellent diagnostic accuracy for detecting endometrial cancer in women who are symptomatic, at high risk, and in general screening populations.
Additional studies are now needed to assess how well it performs as a referral tool compared to the current standard, transvaginal ultrasound.
Research team
Find out more about the SONNET research team
Emma is the SONNET Study Chief Investigator and a Professor of Gynaecological Oncology. Her research interests include screening, prevention and the early detection of gynaecological cancers, as well as developing new treatments and interventions for women with established disease.
Eleanor is a Co-Investigator on the SONNET Study. She is an Academic Clinical Lecturer at The University of Manchester and Specialist Registrar in Obstetrics and Gynaecology. Her research aims to reduce the burden of invasive investigations on women with postmenopausal bleeding by identifying those who are most likely to have an underlying cancer.
Maya is a Co-Investigator on the SONNET Study. She is a Manchester Cancer Research Centre (MCRC) Clinical PhD student and Specialist Registrar in Obstetrics and Gynaecology. Prior to this, she worked with Professor Davidson’s team as a National Institute for Health and Care Research (NIHR) Academic Clinical Fellow.
Kieran is the SONNET Study Coordinator at The University of Manchester. He is responsible for the coordination of study activities and site management, supporting research in the early prevention and detection of gynaecological cancers, with a particular interest in addressing the needs of underrepresented groups.
Suzanne is the SONNET Study Project Manager. She leads on the set-up and delivery of Professor Davidson’s translational research. Her research interests include improving patient experience and outcomes, with particular emphasis on reducing invasive testing and interventions.
Contact us
Get in touch for more information
Suzanne Carter
SONNET Study Project Manager
