An observational study in Gynaecological Cancers, sponsored by University Hospital Southampton NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University Hospital Southampton NHS Foundation Trust · Observational
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.
Participants will be identified by clinically- and research-trained investigators from routine clinical service and their clinical data from electronic NHS databases.
Exclusion Criteria:
Individuals undergoing investigations for suspected gynaecological cancer. Includes those undergoing surgery to reduce their risk of the development of gynaecological cancers in the future.
Individuals with a confirmed gynaecological cancer diagnosis undergoing anti-cancer treatment including surgical resection, chemotherapy or radiotherapy as part of their routine clinical care.
Individuals with a confirmed gynaecological cancer diagnosis undergoing palliative procedures including ascitic drainage as part of their routine clinical care.
Development of a non-invasive diagnostic and prognostic tool for the detection and monitoring of gynaecological cancers using biomarkers in vaginal fluid.
Sequential exploratory analysis of vaginal fluid will be undertaken, such as microbiome, genomic, epigenomic, metabolomic, transcriptomic and phenotypic analysis. This data will be compared with multiomics analysis of paired tissue plus plasma/blood/urine/ascitic fluid then correlated with clinical outcome.
Time frame: From enrolment to 5 years post last participant enrolled
Plan to share: Undecided
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University Hospital Southampton NHS Foundation Trust