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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
Participants will undergo vaginal fluid sampling using the Ellele balloon sampling device
Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer
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.
Time frame: 18 months
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
Time frame: 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.
Time frame: 18 months
Vaginal genomic biomarker variant allele frequency measured from samples collected using the Ellele Sampling Device
Genomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using sequencing-based assays. Outcomes will be reported as variant allele frequency (VAF) for predefined cancer-associated variants.
Time frame: 18 months
Vaginal DNA methylation percentage at predefined CpG loci measured from samples collected using the Ellele Sampling Device
Epigenomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using DNA methylation assays. Outcomes will be reported as methylation percentage (%) at predefined CpG loci.
Time frame: 18 months
Vaginal transcriptomic biomarker expression levels measured from samples collected using the Ellele Sampling Device
Transcriptomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using RNA sequencing-based assays. Outcomes will be reported as normalised gene expression values for predefined transcriptomic biomarkers.
Time frame: 18 months
Vaginal proteomic biomarker concentration or relative abundance measured from samples collected using the Ellele Sampling Device
Proteomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using proteomic assays (e.g., multiplex protein panels or mass spectrometry-based methods). Outcomes will be reported as protein concentration (e.g., ng/mL) or relative abundance for predefined protein biomarkers.
Time frame: 18 months
Vaginal microbiome relative abundance and diversity indices measured from samples collected using the Ellele Sampling Device
Microbiome biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using sequencing-based microbiome profiling methods. Outcomes will be reported as relative microbial abundance (%) of predefined taxa and microbiome diversity indices (e.g. Shannon diversity index).
Time frame: 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.
Time frame: 18 months
Correlation between vaginal sample quality metrics and participant clinical characteristics
Sample quality metrics will be assessed for vaginal samples collected using the Ellele Sampling Device. Sample quality measures will include total nucleic acid yield (ng), nucleic acid integrity metrics (e.g., RNA integrity number or DNA fragment size), and sequencing library quality metrics (e.g., read depth and mapping rate). Clinical characteristics will include participant age (years), body mass index (BMI, kg/m²), and disease stage as recorded in the medical record. Correlations between sample quality metrics and clinical characteristics will be evaluated.
Time frame: 18 months
Correlation between vaginal sample quality metrics and sample collection and processing time variables
Sample quality metrics will be assessed for vaginal samples collected using the Ellele Sampling Device. Sample quality measures will include total nucleic acid yield (ng), nucleic acid integrity metrics (e.g., RNA integrity number or DNA fragment size), and sequencing library quality metrics (e.g., read depth and mapping rate). Logistical variables will include time from sample collection to laboratory processing (hours) and time of day of sample collection (clock time). Correlations between sample quality metrics and logistical variables will be evaluated.
Time frame: 18 months
Calculate enrolment metrics, including numbers of participants given a Patient information sheet, consented and retained.
Time frame: 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).
Acceptability of the Ellele Sampling Device will be assessed in participants who are not undergoing the sampling procedure during surgery. Acceptability will be measured using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates "not painful at all" and 10 indicates "worst pain imaginable." Higher scores indicate greater pain associated with use of the device. The VAS will be completed by participants immediately after use of the device.
Time frame: 18 months
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