Trial to test tampon-based approach for earlier ovarian cancer detection
Women's health company Daye is partnering on the study
A clinical trial launching in Southampton will test whether a specialist medical tampon could help detect ovarian cancer earlier — particularly in women at high genetic risk.
The study, known as VIOLET, is being led by Dr Jemma Longley, consultant medical oncologist at University Hospital Southampton (UHS). Working with colleagues at the Southampton Clinical Trials Unit (SCTU) and the University of Southampton’s Centre for Cancer Immunology, the team will examine whether tiny biological signals found in vaginal fluid could reveal the earliest signs of ovarian cancer.
The trial is sponsored by UHS and funded by The Eve Appeal, with support from the Southampton Experimental Cancer Medicine Centre. Diagnostic tampons used in the study are being supplied by women’s health biotechnology company Daye.
Why earlier diagnosis matters
Ovarian cancer is the sixth most common cancer in women in the UK. On average, 21 people are diagnosed every day. Yet only around 27% of cases are identified at an early stage, when treatment options are broader and survival rates are significantly higher.
There is currently no national screening programme for ovarian cancer. Women with inherited mutations in genes such as BRCA face a much higher lifetime risk of developing the disease. For some, the main preventative option is surgery to remove the ovaries and fallopian tubes — a step that can trigger surgical menopause and long-term health consequences, particularly in younger women.
“There is currently no screening programme available for ovarian cancer, and women with recognised genetic mutations, such as BRCA, may opt to have surgery to remove their ovaries and fallopian tubes to reduce their risk of developing the disease,” says Dr Longley.
“However, this can have significant long-term health effects, by putting younger women into a surgical menopause.
“In the VIOLET study, we will take samples of vaginal fluid from women who are undergoing surgery to reduce their ovarian cancer risk using the diagnostic tampon and vaginal swabs.
“We will also take tissue samples from the removed ovaries and fallopian tubes, and compare the samples from women with the earliest signs of ovarian cancer to those without cancer.
“If we find changes to biomarkers called microRNAs – tiny biological signals that are present in both the ovarian cancer cells and the vaginal fluid – this could indicate a way to predict ovarian cancer in the future.”
MicroRNAs are small molecules that help regulate gene activity. Researchers believe they may act as early warning signals of cancer — potentially detectable before symptoms become obvious.
A familiar product, a new purpose
The concept behind the trial is simple: if early tumour-related signals are shed into vaginal fluid, a tampon — already widely used and non-invasive — could offer a practical way to collect samples.
“For decades, we’ve waited until symptoms worsened significantly to diagnose ovarian cancer, and we know how that story often ends,” said Daye founder Valentina Milanova. “If we are serious about changing outcomes, we have to start earlier. Much earlier.
”The vaginal environment carries biochemical signals from the reproductive tract long before a tumour is clinically visible. The question is not whether signals exist - it’s whether we can detect them reliably, longitudinally, and in a way patients will actually use.
”That’s why this study matters.”
The VIOLET study is currently recruiting women who are already scheduled for risk-reducing surgery at UHS. By comparing vaginal fluid samples with tissue taken from removed ovaries and fallopian tubes, researchers hope to determine whether microRNA changes reliably reflect the earliest stages of cancer development.
Mr David Constable-Phelps, consultant gynaecological oncology surgeon at UHS and co-investigator on the study, says the potential impact could be significant.
“The ability to detect the earliest signs of ovarian cancer, with a relatively non-invasive test such as the Daye tampon, would be a complete game-changer for women with ovarian cancer,” he says.
“Ovarian cancer commonly has non-specific symptoms in its early and late stages, so the tumour can spread to other organs silently.
“We are really optimistic that we will find interesting biological signals in the vaginal fluid of women with early-stage tumours, meaning more women can expect to be cured. This study will pave the way towards further translational work to allow us to understand more about the biology of these cancers.”
Women living with risk
For women like Charlotte Stehr, 35, who was diagnosed with a BRCA mutation in 2020, the stakes are deeply personal. After undergoing a double mastectomy due to increased breast cancer risk, she remains under oncology care — and acutely aware of her ongoing ovarian cancer risk.
“I am under the care of the oncology team since my mastectomy, but I’m just so scared that I will just slip through the cracks,” she says. “At the moment I am not recommended for preventative surgery to remove my ovaries because I’m under 40.”
She believes that a reliable screening approach could change the landscape for high-risk women.
“I don’t want future generations, or other women like me with a known risk factor, being in this same position. Or someone losing their mum at 40 because cancer wasn’t picked up in time.
“I think this sort of research is amazing. Women have been using tampons for years, so why would you not want to use one that could actually help you?”
Alison Farmer, now 65, knows first-hand how rare early diagnosis can be. Diagnosed with ovarian cancer at 40 after pushing for further investigation into unusual bleeding, she credits early intervention with saving her life.
“If I hadn’t been a nurse and pushed for further tests, I probably wouldn’t be here today,” she says.
“Research into screening and earlier diagnosis is absolutely vital. Far too many women are still diagnosed too late.”
What happens next
Dr Victoria Goss, Head of Early Diagnosis and Translational Research at the SCTU and co-investigator on the trial, describes the study as addressing an urgent unmet need.
“This is an exciting trial in an area where better diagnosis is desperately needed,” she says, noting that it aligns with broader national efforts to address inequalities in women’s healthcare.
If the VIOLET study identifies reliable biomarkers in vaginal fluid, Dr Longley says the next step would be a much larger trial — potentially moving towards a community-based screening test for women at high risk.
That remains some way off. But for a disease where symptoms are often subtle and diagnosis frequently delayed, even the possibility of a non-invasive early warning tool represents a significant shift in thinking.