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

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

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.

Inclusion Criteria:

1. 18 years old or over at time of consent for study
2. Be able to give voluntary, written informed consent to participate in the study
3. Attending secondary gynaecology services
4. Able to tolerate a vaginal speculum examination or a tampon

Exclusion Criteria:

1. Vaginal, vulval or perineal symptoms make vaginal examination inappropriate
2. History of allergic reactions to polypropylene and/or nylon and/or nitrile and/or barrier contraception
3. Current pregnancy or suspicion of pregnancy
4. Known Hepatitis B or C, HIV, HTLV-II or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease)
5. Undergone pelvic radiotherapy within the last 6 weeks
6. Undergone systemic chemotherapy, immunotherapy, or received a novel pharmaceutical agent for malignancy within the last 3 weeks
7. Previously undergone hysterectomy or absence of a uterus
8. Clinician-determined exclusion for medical or social reasons