A groundbreaking trial will investigate whether a specialist medical tampon could help identify the earliest indicators of ovarian cancer. The test searches for minuscule biological markers in vaginal fluid and has the potential to be a "complete game-changer" for the condition, which is typically diagnosed at a late stage.


Around 250 women are being enrolled for the trial, called Violet and overseen by researchers in Southampton. Participants will include patients who have received an ovarian cancer diagnosis and are undergoing ovary removal, alongside women carrying the BRCA gene mutation who are opting for risk-reducing surgery. Those with this genetic mutation face an elevated risk of developing various cancers, including breast and ovarian.


Dr Jemma Longley, consultant medical oncologist at University Hospital Southampton and chief investigator for the trial, said: "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. However, this can have significant long-term health effects by putting younger women into a surgical menopause."



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Researchers will gather samples of vaginal fluid using the medical tampon and swabs. They will also extract tissue from the excised ovaries and fallopian tubes and compare them with those from women without the condition.


The specimens will undergo analysis to detect the earliest indicators of ovarian cancer, with scientists searching for alterations in biomarkers called microRNAs, minuscule biological markers found in both ovarian cancer cells and vaginal fluid. Approximately 7,600 new ovarian cancer cases occur annually in the UK.


Nevertheless, a significant proportion are identified at an advanced stage. Biotechnology firm Daye has created the diagnostic tampon. Should Violet prove successful, researchers hope to pursue a more extensive trial.


David Constable-Phelps, consultant gynaecological oncology surgeon and co-investigator for the research, said: "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. 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."



Athena Lamnisos, chief executive of The Eve Appeal, which contributed funding to the research, said: "Anyone with an altered BRCA gene faces very difficult decisions around their health and family planning."


She anticipates the research might result in "a simple and easy-to-use test" that could offer tailored information to individuals navigating the decision-making process.


She added: "It could both help them reduce their risk of ovarian cancer development or pick it up in the earliest stages, when it is most treatable."

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