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

NCT07622953 | Recruiting

• 1 other identifier: RHM CAN1897
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynaecological Cancers

Keywords

Gynaecological cancers; Biomarker; Multi-Cancer Early Detection

Outcome Measures

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.

  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.

  From enrolment to 5 years post last participant enrolled

Study Arms (3)

Suspected for Gynaecological Cancers

Individuals undergoing investigations for suspected gynaecological cancer. Includes those undergoing surgery to reduce their risk of the development of gynaecological cancers in the future.

Confirmed Gynaecological Cancer

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 Gynaecological Cancer

Individuals with a confirmed gynaecological cancer diagnosis undergoing palliative procedures including ascitic drainage as part of their routine clinical care.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified by clinically- and research-trained investigators from routine clinical service and their clinical data from electronic NHS databases.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Experimental Cancer Medicine Centres: collaborator
• Daye BioTech: collaborator
• University of Oxford: collaborator
• Southampton Clinical Trials Unit: collaborator
• The Eve Appeal: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, vaginal fluid, primary tissue and ascitic fluid

Study Officials

• Dr Jemma Longley

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Jemma Longley

CONTACT

023 8120 5154; violetstudy@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 3, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): March 2, 2030
• Study Completion (Estimated): July 2, 2030
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

GB (1)