Gynaecological CancersVIOLETNCT07622953
Vaginal Fluid Derived Biomarkers in the Early Detection and Evolution of Gynaecological Cancers
An observational study of Gynaecological Cancers, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecological Cancers
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2026to 2 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified by clinically- and research-trained investigators from routine clinical service and their clinical data from electronic NHS databases.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Dr Jemma Longley, 023 8077 7222, violetstudy@uhs.nhs.uk
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to 5 years post last participant enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start14 Jan 2026
- Primary completion2 Mar 2030 (estimated)
- Study completion2 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecological CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Experimental Cancer Medicine Centres, The Eve Appeal, Southampton Clinical Trials Unit, Daye BioTech, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Dr Jemma Longley, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622953
- Sponsor's protocol ID
- RHM CAN1897
- Acronym
- VIOLET
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Fluid Derived Biomarkers in the Early Detection and Evolution of Gynaecological Cancers
- ClinicalTrials.gov ID
- NCT07622953
- Acronym / sponsor ID
- VIOLET / RHM CAN1897
- Conditions
- Gynaecological Cancers
- Keywords
- Gynaecological cancers, Biomarker, Multi-Cancer Early Detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Experimental Cancer Medicine Centres, The Eve Appeal, Southampton Clinical Trials Unit, Daye BioTech, University of Oxford
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 2 Mar 2030 (estimated)
- Study completion
- 2 Jul 2030 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified by clinically- and research-trained investigators from routine clinical service and their clinical data from electronic NHS databases.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Jemma Longley principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynaecological Cancers, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Jemma Longley (023 8120 5154, violetstudy@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.