Comparing molecular and imaging techniques for the detection of womb cancer in black women

A comparative study of epigenetic analysis and ultrasonography for endometrial cancer detection in black women with abnormal vaginal bleeding

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12265297

Enrollment

400

Registered

2024-02-16

Start date

2024-01-23

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial cancer Cancer

Interventions

This study will evaluate the accuracy of a novel epigenetic test, the WID™-qEC test, in detecting endometrial cancer in black women. WID™-qEC test performance will be assessed using vaginal and cervic

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women aged 50 years and above 2. Experiencing abnormal vaginal bleeding warranting ultrasound examination 3. Able to give informed consent 4. Fall under one of the following self-defined ethnic categories: 4.1. Black, African, or Caribbean 4.2. Mixed/ multiple ethnic groups (Black African or Caribbean and other ethnic background)

Exclusion criteria

Exclusion criteria: 1. Current hormone replacement therapy (HRT) use 2. History of hysterectomy

Design outcomes

Primary

Measure	Time frame
The 'real world' diagnostic performance (sensitivity, specificity, positive and negative predictive values) of the WIDTM-qEC test as first-line triage for a cohort of women from the ‘Black’ and ‘Black Mixed’ ethnic groups referred with abnormal vaginal bleeding. WIDTM-qEC test and ultrasound diagnostic performance will be measured when the patient initially presents to the hospital. Vaginal sample is taken at the time of the initial ultrasound scan. Where endometrial sampling or hysterectomy is required, this will typically occur within 4 weeks.	—

Measure

Time frame

The 'real world' diagnostic performance (sensitivity, specificity, positive and negative predictive values) of the WIDTM-qEC test as first-line triage for a cohort of women from the ‘Black’ and ‘Black Mixed’ ethnic groups referred with abnormal vaginal bleeding. WIDTM-qEC test and ultrasound diagnostic performance will be measured when the patient initially presents to the hospital. Vaginal sample is taken at the time of the initial ultrasound scan. Where endometrial sampling or hysterectomy is required, this will typically occur within 4 weeks.

—

Secondary

Measure	Time frame
1. Number of ultrasound and other imaging investigations required in WIDTM-qEC true-positive and false-negative patients to reach a histological diagnosis, measured using ultrasound +/- Pipelle biopsy at initial presentation, and hysteroscopy/endometrial biopsy and/or hysterectomy 1-4 weeks later, respectively. 2. Stage, histology, and grade of disease at diagnosis and relation to WIDTM-qEC and TVUS findings, measured using surgical staging of histopathology specimens after a hysterectomy (+/- other procedures) has been performed, typically within 4 weeks. 3. Rates of inconclusive results with both the WIDTM-qEC test and TVUS, measured using the number of diagnostic procedures carried out throughout the patient’s journey to assess the cause of abnormal vaginal bleeding.	—

Measure

Time frame

1. Number of ultrasound and other imaging investigations required in WIDTM-qEC true-positive and false-negative patients to reach a histological diagnosis, measured using ultrasound +/- Pipelle biopsy at initial presentation, and hysteroscopy/endometrial biopsy and/or hysterectomy 1-4 weeks later, respectively. 2. Stage, histology, and grade of disease at diagnosis and relation to WIDTM-qEC and TVUS findings, measured using surgical staging of histopathology specimens after a hysterectomy (+/- other procedures) has been performed, typically within 4 weeks. 3. Rates of inconclusive results with both the WIDTM-qEC test and TVUS, measured using the number of diagnostic procedures carried out throughout the patient’s journey to assess the cause of abnormal vaginal bleeding.

—

Countries

England, United Kingdom

Contacts

Public ContactOjone Illah

o.illah@ucl.ac.uk+44 (0)203 108 2003

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026