An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device

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.

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.

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.

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.

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.

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).

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.

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.

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.