A new clinical trial in Southampton is exploring the potential of a special medical tampon designed to detect the earliest signs of ovarian cancer. This innovative test aims to identify biological signals in vaginal fluid, marking a significant shift in how the disease is diagnosed. Currently, ovarian cancer is often identified at advanced stages, which complicates treatment outcomes.
The trial, named Violet, will recruit approximately 250 women, including patients diagnosed with ovarian cancer who are undergoing surgery to remove their ovaries, as well as women carrying the BRCA gene mutation. Individuals with this mutation are at a heightened risk for several cancers, including breast and ovarian cancers.
Dr. Jemma Longley, a consultant medical oncologist at University Hospital Southampton and the trial’s chief investigator, highlighted the absence of a screening program for ovarian cancer. She noted that many women, particularly those with recognized genetic mutations, may opt for preventive surgeries that can lead to surgical menopause and significant long-term health consequences.
Researchers will use the medical tampon to collect samples of vaginal fluid, alongside tissue samples from the removed ovaries and fallopian tubes. These samples will undergo analysis to identify early indicators of ovarian cancer by focusing on changes in biomarkers known as microRNAs. These tiny biological signals are found in both ovarian cancer cells and vaginal fluid.
In the UK, there are approximately 7,600 new ovarian cancer cases diagnosed each year, with most detected at later stages, complicating treatment. The diagnostic tampon has been developed by the biotechnology company Daye. Should the Violet trial yield promising results, the researchers hope to expand their efforts with a larger follow-up study.
David Constable-Phelps, a consultant gynaecological oncology surgeon and co-investigator of the study, expressed optimism about the potential impact of this research. He stated, “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 emphasized that the disease often presents non-specific symptoms early on, allowing it to spread silently to other organs.
Athena Lamnisos, the chief executive of The Eve Appeal, which has partially funded the study, remarked on the challenging decisions faced by individuals with the altered BRCA gene. She is hopeful that this research could lead to a “simple and easy-to-use test” that could provide personalized information to those navigating health and family planning decisions. Lamnisos added, “It could help them reduce their risk of ovarian cancer development or pick it up in the earliest stages, when it is most treatable.”
The Violet trial represents a promising advancement in the early detection of ovarian cancer, with the potential to significantly improve outcomes for women at risk.
