Ellele-02: Exploratory Study Launch Announcement

Ellele Health has launched Ellele-02, a multi-site exploratory study aimed at advancing the early detection of gynaecological cancers.

The study is being conducted across two NHS sites: the Royal Infirmary of Edinburgh and Queen Elizabeth Hospital, Gateshead. Ellele-02 will explore the ability to detect novel biomarkers associated with endometrial and ovarian cancers from vaginal samples collected using the Ellele Sampling Device.

Ellele-02 will recruit multiple participant cohorts, including individuals with confirmed endometrial and ovarian cancer alongside matched control participants. A dedicated research and development cohort will also be recruited to support optimisation of sample collection and processing.

Key objectives of the study include determining the ability to stratify cancer cases from controls using vaginal samples, assessing DNA quality and quantity, and validating DNA processing methodologies and multi-omics analysis pipelines. Where available, vaginal samples will be compared with matched clinical specimens such as blood, urine, ascitic fluid, or tumour tissue to better understand concordance across sample types.

Participant experience is a core focus of the study, with acceptability and comfort assessed using a standard discomfort scale following use of the Ellele Sampling Device.

The launch of Ellele-02 marks an important step forward in Ellele Health’s mission to develop novel cancer diagnostics.