Clinical Trial

Vaginal Fluid Derived Biomarkers in the Early Detection and Evolution of Gynaecological Cancers

Study acronym: VIOLET
Recruiting
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Summary
This study will investigate vaginal secretions in those patients with cancer versus those who are cancer free and compare changes in specific markers that change when a cancer first develops. Patients who are being investigated for any gynaecological cancer, undergoing surgery to reduce their risk of gynaecological cancer and those with confirmed gynaecological cancer undergoing anti-cancer treatment will be approached to take part in this study. Participants will be asked to provide an extra blood test, urine sample and high vaginal swab in addition to surplus primary tissue and ascitic fluid that is left over from routine surgical procedures. Specific markers will be compared in patients who have evidence of gynaecological cancer versus those that do not. Changes in these markers during anti-cancer treatment will also be compared to see how these change over time. This could improve the detection and monitoring of gynaecological cancers in those people at highest risk of developing it by using non-invasive multi-cancer early detection tests developed at the University of Southampton.
Trial Details
NCT Number NCT07622953
Lead Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators: Experimental Cancer Medicine Centres, The Eve Appeal, Southampton Clinical Trials Unit, Daye BioTech, University of Oxford
Conditions Gynaecological Cancers
Enrollment 250 participants
Start Date 2026-01-14
Primary Completion 2030-03-02 (estimated)
Study Completion 2030-07-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-03