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

Overview

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.

Interventions

• Device Ellele Sampling Device
  Participants will undergo vaginal fluid sampling using the Ellele balloon sampling device

Primary outcome measures

• Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer [Time frame: 18 months]

Secondary outcome measures (12)

• 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 [Time frame: 18 months]
• Vaginal DNA methylation percentage at predefined CpG loci measured from samples collected using the Ellele Sampling Device [Time frame: 18 months]
• Vaginal transcriptomic biomarker expression levels measured from samples collected using the Ellele Sampling Device [Time frame: 18 months]
• Vaginal proteomic biomarker concentration or relative abundance measured from samples collected using the Ellele Sampling Device [Time frame: 18 months]
• Vaginal microbiome relative abundance and diversity indices measured from samples collected using the Ellele Sampling Device [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 [Time frame: 18 months]
• Correlation between vaginal sample quality metrics and sample collection and processing time variables [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). [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07429799 · 349070

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗