VIOLET
Research type
Research Study
Full title
Vaginal fluid derived bIOmarkers in the earLy dEtecTion and evolution of Gynaecological Cancers
IRAS ID
356418
Contact name
Jemma Longley
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Many gynaecological cancers are diagnosed at a late stage when the chance of cure is low. Current tests used to identify these cancers are not reliable when the cancer is in its early stages and the chance of cure is high. We therefore need to develop new tests to identify these cancers when there are minimal or no symptoms in those people at the highest risk of developing them. The unique microenvironment of vaginal fluid potentially reflects local tumour activity in gynaecological cancers, offering a unique opportunity for screening and treatment monitoring. This study will investigate vaginal secretions in those patients with cancer versus those who are cancer free and comparing changes in specific markers that change when a cancer first develops. Patients who are being investigated for any gynaecological cancer, patients undergoing surgery to reduce their gynaecological cancer risk and those with confirmed gynaecological cancer undergoing anti-cancer treatment will be approached to take part in this study. We will ask these patients for an extra blood test, urine sample and a high vaginal swab in addition to surplus primary tissue and ascitic fluid that is left over from routine surgical procedures. Specific markers in vaginal secretions, primary tumour and ascitic fluid will be compared in patients who have evidence of gynaecological cancer versus those that do not. We will also compare changes in these markers during anti-cancer treatment to see how these evolve over time. This could improve the detection and monitoring of gynaecological cancers in those people at highest risk of developing it by using a high vaginal swab test that can be used to screen/monitor patients and a point of care test to establish cancer type, site and stage using multi-detection early detection tools developed at the University of Southampton.
REC name
North West - Haydock Research Ethics Committee
REC reference
25/NW/0236
Date of REC Opinion
31 Jul 2025
REC opinion
Favourable Opinion