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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Dr Jemma Longley
- 전화번호: 023 8120 5154
- 이메일: violetstudy@uhs.nhs.uk
연구 장소
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Southampton, 영국, SO16 6YD
- 모병
- University Hospital Southampton NHS Foundation Trust
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연락하다:
- Dr Jemma Longley
- 전화번호: 023 8077 7222
- 이메일: violetstudy@uhs.nhs.uk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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.
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Dr Jemma Longley, University Hospital Southampton NHS Foundation Trust
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- RHM CAN1897
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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