RecruitingOBSERVATIONAL

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

Researchers are investigating if certain markers found in vaginal fluid can help detect gynaecological (female reproductive organ) cancers early and track them during treatment. The study will compare these markers in people who have cancer, those being checked for cancer, and those who don't have cancer. Participants will be asked to provide extra blood and urine samples, and a vaginal swab. Some might also provide tissue or fluid left over from routine surgery. The aim is to develop new, simple tests that could find gynaecological cancers sooner, especially for those at higher risk, potentially improving treatment outcomes.

At a glance

Status

Recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

250

Start

14 Jan 2026

Estimated completion

02 Jul 2030

Gynaecological Cancers

What is this study about?

This study is looking at ways to detect gynaecological cancers – cancers that affect a woman's reproductive organs like the womb, ovaries, or cervix – at an earlier stage. Researchers believe that certain natural substances, called 'markers', found in fluid from the vagina might change when cancer first starts to develop. By studying these markers, they hope to create new tests that can find cancer much sooner.

The study involves looking at samples from people who are either being checked for gynaecological cancer, those who are having surgery to lower their risk of getting cancer, or those who have been diagnosed with gynaecological cancer and are receiving treatment. Researchers will compare the markers in these groups to see what changes occur when cancer is present.

The goal is to develop simple, non-invasive (meaning they don't involve surgery) tests that could help find gynaecological cancers early, especially in people who are at higher risk. These tests could also help doctors understand if treatments are working over time. Finding cancers earlier often means treatments can be more effective.

Key takeaways

Researchers are exploring new ways to detect gynaecological cancers early.
The study uses samples like vaginal fluid, blood, and urine.
It compares markers in people with and without cancer.
Aims to create simpler, non-invasive cancer detection tests.
Participation involves providing extra samples during routine care.

Who may be eligible?

This study is looking for women who are 18 years or older.

You might be able to join if you are currently being checked for a gynaecological cancer, or if you are having surgery to reduce your risk of developing gynaecological cancer in the future. We are also looking for people who have already been diagnosed with a gynaecological cancer and are currently receiving treatment, or those who are having procedures for advanced gynaecological cancer, such as fluid drainage.

However, you cannot take part if you are under 18, pregnant, breastfeeding, or if you have a vaginal infection. If you've taken antibiotics in the last week, or if you have a history of other cancers or long-term inflammatory conditions, you also won't be able to join. You must also be able to understand what the study involves and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently being checked for gynaecological cancer or having risk-reduction surgery?
Do you have a gynaecological cancer diagnosis and are currently receiving treatment?
Are you NOT pregnant or breastfeeding?
Have you NOT had antibiotics in the last week?
Do you NOT have a current vaginal infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide some extra samples. These will include an additional blood test, a urine sample, and a vaginal swab (a simple cotton swab to collect fluid from the vagina). If you are having surgery, you may also be asked if extra tissue or fluid that is left over from your routine procedure can be used for the study. Doctors would usually discard these leftover samples. These sample collections will happen at different times, depending on whether you are being investigated for cancer, having risk-reducing surgery, or are undergoing cancer treatment. The total duration of your participation will depend on your individual circumstances and treatment plan.

Potential risks and benefits

A potential benefit of taking part is contributing to research that could lead to earlier and simpler detection methods for gynaecological cancers, potentially improving future patient care. However, there is no direct personal benefit from taking part in this study. The main risks are minimal and include the slight discomfort from an extra blood draw or vaginal swab. You are free to withdraw from the study at any time without giving a reason, and this will not affect your routine medical care in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is a gynaecological cancer?

Gynaecological cancers are cancers that affect a woman's reproductive organs, such as the ovaries, womb, cervix, vagina, or vulva.

What are 'biomarkers'?

Biomarkers are natural substances in the body that can indicate a disease or how the body responds to a treatment. In this study, we're looking for specific markers in vaginal fluid.

Will taking part affect my regular medical treatment?

No, taking part in this study will not affect your standard medical care or treatment in any way.

What is a 'high vaginal swab'?

A high vaginal swab is a simple, quick procedure where a small cotton swab is used to gently collect fluid from inside the vagina.

Will I get my test results from the study?

The study aims to develop new tests for the future, so individual results from the research samples will not be provided directly back to participants.

How to find out more

Dr Jemma Longley

violetstudy@uhs.nhs.uk 023 8120 5154 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.