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NCT Number: NCT07622953

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

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.

Recruiting

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Key information

Conditions

Gynaecological Cancers

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location status: Recruiting

Location contact

Dr Jemma Longley

CONTACT

[email protected]

023 8077 7222

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of a non-invasive diagnostic and prognostic tool for the detection and monitoring of gynaecological cancers using biomarkers in vaginal fluid.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Jemma Longley

CONTACT

[email protected]

023 8120 5154

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

  • Daye BioTech
  • Experimental Cancer Medicine Centres
  • Southampton Clinical Trials Unit
  • The Eve Appeal
  • University of Oxford

Registry information

Acronym: VIOLET

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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