Ellele-02
Research type
Research Study
Full title
An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device
IRAS ID
349070
Contact name
Andrew Horne
Contact email
Sponsor organisation
Ellele Health Ltd
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
This exploratory study aims to identify biomarkers for diagnosing conditions of the female reproductive tract, particularly endometrial and ovarian cancers, by analysing vaginal mucosa samples collected using the Ellele Sampling device.
The Ellele01 study demonstrated that the device is acceptable to women, easy to use, and can yield high-quality DNA suitable for sequencing methods. This makes it a feasible alternative to invasive diagnostic methods.
Studies have shown that endometrial cancer cells and DNA are present in the vagina, suggesting that it can be used for non-invasive testing. This provides a strong biological basis for the Ellele device’s ability to collect material containing biomarkers indicative of endometrial cancer. Ovarian cancer also holds promise for detection via this approach.
The study plans to enrol approximately 300 participants, from 2 Secondary NHS centre, to allow for 250 analysable samples from 50 participants with endometrial cancer, 50 with ovarian cancer, and 50 controls for each cancer type, and 50 participants for sample analysis optimisation totalling 300 participants.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0198
Date of REC Opinion
8 Oct 2025
REC opinion
Further Information Favourable Opinion