An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ellele Health
- Enrollment
- 300
- Primary Endpoint
- Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer
Overview
Brief Summary
An exploratory study of early detection and investigation of gynaecological diseases
Throughout a woman's life, she may need tests that can feel uncomfortable, such as a smear test or a biopsy taken through the vagina. These tests are important for diagnosing and monitoring women's health. Detecting gynaecological cancers - like ovarian and endometrial cancer - can be difficult because symptoms are often vague, and current tests can be invasive and may require multiple hospital visits.
Ellele Health has developed a new medical device called the Ellele Sampling Device. This device is designed to gently collect a sample from the vaginal wall. Early studies have shown it can collect enough cells for laboratory analysis, with the potential to detect gynaecological conditions in a way that is less invasive and more comfortable than existing tests.
In this study, the investigators will use the Ellele Device to collect samples from both cancer patients and patients considered to be comparative controls. Taking part does not mean the patient has cancer or that the patient is being tested for cancer. The sample will only be used for research. The aim is to see whether this new device can pick up biological markers linked to endometrial and ovarian cancer and to assess how easy it is to use in a clinical setting. The findings could help improve early detection and reduce the need for more invasive procedures in the future.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years old or over at time of consent for study
- •Be able to give voluntary, written informed consent to participate in the study
- •Attending secondary gynaecology services
- •Able to tolerate a vaginal speculum examination or a tampon
Exclusion Criteria
- •Vaginal, vulval or perineal symptoms make vaginal examination inappropriate
- •History of allergic reactions to polypropylene and/or nylon and/or nitrile and/or barrier contraception
- •Current pregnancy or suspicion of pregnancy
- •Known Hepatitis B or C, HIV, HTLV-II or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease)
- •Undergone pelvic radiotherapy within the last 6 weeks
- •Undergone systemic chemotherapy, immunotherapy, or received a novel pharmaceutical agent for malignancy within the last 3 weeks
- •Previously undergone hysterectomy or absence of a uterus
- •Clinician-determined exclusion for medical or social reasons
Arms & Interventions
Ellele Sampling Device
Intervention: Ellele Sampling Device (Device)
Outcomes
Primary Outcomes
Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer
Time Frame: 18 months
For each participant, predefined molecular biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device. Biomarkers will be assessed quantitatively, including normalised read counts or variant allele frequency for genomic and transcriptomic biomarkers, methylation percentage at selected CpG loci for epigenomic biomarkers, protein concentration or relative abundance for proteomic biomarkers, and relative microbial abundance (%) and diversity indices for microbiome biomarkers. Correlations between biomarker measures and clinical diagnosis of endometrial or ovarian cancer will be evaluated.
Secondary Outcomes
- Calculate DNA extraction QC pass/failure rates, as defined in Ellele-01, to verify technology compatibility across disease cohorts (e.g. ovarian cancer, endometrial cancer) and participants where no cancer has been identified(18 months)
- By using laboratory and data QC metrics for each 'omic assessed (e.g transcriptomics, methylation analysis etc) to calculate pass/failure rates, for assessment of technology compatibility.(18 months)
- Use pairwise concordance analysis of 'omic signatures between vaginal mucus samples and appropriate available matched samples (e.g. ascitic fluid, tumour blocks) where feasible.(18 months)
- Vaginal genomic biomarker variant allele frequency measured from samples collected using the Ellele Sampling Device(18 months)
- Vaginal DNA methylation percentage at predefined CpG loci measured from samples collected using the Ellele Sampling Device(18 months)
- Vaginal transcriptomic biomarker expression levels measured from samples collected using the Ellele Sampling Device(18 months)
- Vaginal proteomic biomarker concentration or relative abundance measured from samples collected using the Ellele Sampling Device(18 months)
- Vaginal microbiome relative abundance and diversity indices measured from samples collected using the Ellele Sampling Device(18 months)
- Correlation between vaginal sample quality metrics and participant clinical characteristics(18 months)
- Correlation between vaginal sample quality metrics and sample collection and processing time variables(18 months)
- Calculate enrolment metrics, including numbers of participants given a Patient information sheet, consented and retained.(18 months)
- Acceptability of the Ellele Sampling Device measured using a Visual Analogue Scale measured after use (only on patients who are not undergoing the procedure during surgery).(18 months)