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

NCT07429799 | Not Yet Recruiting DMC

• 1 other identifier: 349070
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Cancer; Endometrial Cancer

Keywords

Ovarian Cancer; Endometrial Cancer; Early detection

Outcome Measures

Primary Outcomes (1)

• Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer

  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.

  18 months

Secondary Outcomes (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

  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.

  18 months

• Vaginal genomic biomarker variant allele frequency measured from samples collected using the Ellele Sampling Device

  18 months

• Vaginal DNA methylation percentage at predefined CpG loci measured from samples collected using the Ellele Sampling Device

  18 months

• Vaginal transcriptomic biomarker expression levels measured from samples collected using the Ellele Sampling Device

  18 months

Study Arms (1)

Ellele Sampling Device

EXPERIMENTAL

Device: Ellele Sampling Device

Interventions

Ellele Sampling Device DEVICE

Participants will undergo vaginal fluid sampling using the Ellele balloon sampling device

Ellele Sampling Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ellele Health: lead
• Gateshead Health NHS Foundation Trust: collaborator
• Royal Infirmary of Edinburgh: collaborator

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• James May

  Royal Infirmary of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagulendram

CONTACT

0131 536 1000; ovia.nagulendram@nhs.net

Neil Ryan

CONTACT

0131 536 1000; neilryan@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 24, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): February 6, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share