Vaginal Biomarkers for Early Gynaecological Cancers
Official title: Vaginal Fluid Derived Biomarkers in the Early Detection and Evolution of Gynaecological Cancers
Run by University Hospital Southampton NHS Foundation Trust · NCT07622953 · Data updated 2026-11-12
This study tests whether markers in vaginal secretions differ between people with and without gynaecological cancers to help detect cancers earlier and monitor treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Southampton) |
| Status | Recruiting |
| Started | January 14, 2026 |
| Main results expected | March 2, 2030 |
| Study ends | July 2, 2030 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07622953 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals being investigated for suspected gynaecological cancer, those undergoing risk-reducing surgery, or individuals with confirmed gynaecological cancer receiving treatment.
✕Probably not a fit
Patients with other health issues or non-gynaecological conditions may not benefit from this biomarker-focused study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will compare markers in vaginal secretions, blood, urine, and surplus tissue from people undergoing routine procedures related to gynaecological cancers. The study includes those being investigated for cancer, those having cancer-prevention surgeries, and those with confirmed cancer undergoing treatment. Samples are collected alongside standard care and analyzed over time to see how marker levels change with treatment and disease development. The goal is to improve early detection and tracking of gynaecological cancers using non-invasive or minimally invasive methods.
Why it matters
Potential benefit: If successful, the approach could lead to earlier detection and better monitoring of gynaecological cancers.
How similar studies have gone: Previous work in related cancer biomarker research has shown promise, but this exact vaginal biomarker approach is still being explored for consistency and applicability.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom Recruiting
Study contacts
- Principal investigator: Dr Jemma Longley — University Hospital Southampton NHS Foundation Trust
- Study coordinator: Dr Jemma Longley
- Email: violetstudy@uhs.nhs.uk
- Phone: 023 8120 5154
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Methylation markers in self-samples to help detect gynecological cancers
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HER2 expression across Brazilian gynecologic cancers
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.