EASY - CARE
Research type
Research Study
Full title
Prospective, interventional cohort trial of WID-easy test performance for detection of womb cancer in women with abnormal uterine bleeding
IRAS ID
357394
Contact name
Nicola MacDonald
Contact email
Sponsor organisation
Sola Diagnostics
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Womb cancer is a common type of cancer that affects the womb lining. The main symptom of womb cancer is abnormal vaginal bleeding. However, only a small percentage of women with abnormal bleeding have womb cancer. This means many women undergo unnecessary and invasive tests to check for cancer. There are challenges in diagnosing womb cancer early. Standard of care which are ultrasound scans are often not specific, leading to many women being referred for invasive tests.
The WID-easy test may help improve the diagnosis of womb cancer. The test looks for specific changes in the DNA in a cervicovaginal sample. The sample is taken by a healthcare professional using a simple cotton swab.
This research project aims to gather the information needed to support the use of the WID-easy test in NHS hospital sites. We will conduct a clinical trial in 2,000 women referred to a hospital clinic because of abnormal vaginal bleeding. Follow up Data collection will occur at 3 months and 12 months from enrolment. All women in the trial will also undergo standard of care , a ultrasound scan.
At recruitment, women will be informed of the small possibility of needing a call-back on receipt of a positive WID-easy result, if further testing has not been indicated based on the Ultrasound result, a letter will be sent explaining the test result and inviting them to attend an appointment for a hysteroscopy under general anaesthetic .
The trial participants will also be invited to complete an optional questionnaire about their experience of the test at the end of their pathway. Participants will also be offered an opportunity to provide further feedback in the form of 1:1 Interviews.
The Questionnaire and the topic guide for the interviews will be co-designed with members the community who have had lived experience of the condition.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
25/EE/0200
Date of REC Opinion
31 Oct 2025
REC opinion
Further Information Favourable Opinion