Vaginal Fluid Derived Biomarkers in the Early Detection and Evolution of Gynaecological Cancers (VIOLET)
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Dr Jemma Longley
- Telefonnummer: 023 8120 5154
- E-mail: violetstudy@uhs.nhs.uk
Studiesteder
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Southampton, Det Forenede Kongerige, SO16 6YD
- Rekruttering
- University Hospital Southampton NHS Foundation Trust
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Kontakt:
- Dr Jemma Longley
- Telefonnummer: 023 8077 7222
- E-mail: violetstudy@uhs.nhs.uk
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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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.
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Confirmed Palliative Gynaecological Cancer
Individuals with a confirmed gynaecological cancer diagnosis undergoing palliative procedures including ascitic drainage as part of their routine clinical care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Development of a non-invasive diagnostic and prognostic tool for the detection and monitoring of gynaecological cancers using biomarkers in vaginal fluid.
Tidsramme: From enrolment to 5 years post last participant enrolled
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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.
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From enrolment to 5 years post last participant enrolled
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dr Jemma Longley, University Hospital Southampton NHS Foundation Trust
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RHM CAN1897
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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