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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07622953

Acronym

VIOLET

Enrollment

250

Registered

2026-06-03

Start date

2026-01-14

Completion date

2030-07-02

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynaecological Cancers

Keywords

Gynaecological cancers, Biomarker, Multi-Cancer Early Detection

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Suspected cohort: Individuals undergoing investigations for suspected gynaecological cancer. This includes patients undergoing surgery to reduce their risk of the development of gynaecological cancers in the future * Confirmed treatment cohort: Individuals with a confirmed gynaecological cancer diagnosis undergoing anti-cancer treatment including surgical resection, chemotherapy or radiotherapy as part of their routine clinical care * Confirmed palliative cohort: Individuals with a confirmed gynaecological cancer diagnosis undergoing palliative procedures including ascitic drainage as part of their routine clinical care

Exclusion criteria

* Patients under 18 years old * Individuals who lack capacity to consent to trial participation * Pregnant or breastfeeding patients * Patients with active vaginal infection * Patients currently on or having received antibiotics within the previous week * History of prior malignancy or chronic inflammatory disease

Design outcomes

Primary

Measure	Time frame	Description
Development of a non-invasive diagnostic and prognostic tool for the detection and monitoring of gynaecological cancers using biomarkers in vaginal fluid.	From enrolment to 5 years post last participant enrolled	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.

Countries

United Kingdom

Contacts

CONTACTDr Jemma Longley

violetstudy@uhs.nhs.uk023 8120 5154

PRINCIPAL_INVESTIGATORDr Jemma Longley

University Hospital Southampton NHS Foundation Trust

Outcome results