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

Sponsor: University Hospital Southampton NHS Foundation Trust

NCT ID: NCT07622953

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 54 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
Female
Number of participants
250
Started
2026-01-14
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for gynaecological cancers
  • • Clinical study - 250 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with gynaecological cancers
  • • Female only

Where?

  • • Southampton - University Hospital Southampton NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Gynaecological Cancers

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

What the study is looking for

  • ✓Confirmed palliative cohort: Individuals with a confirmed gynaecological cancer diagnosis undergoing palliative...

Who cannot take part

  • ✗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
See the full criteria
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

Where Is This Study? (1 UK site)

University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Dr Jemma Longley

Sponsor contact

CONTACT

023 8120 5154 violetstudy@uhs.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-05