A simple DNA test on a cervical sample could replace ultrasound as the first step in diagnosing womb cancer, potentially cutting unnecessary referrals by up to 88%. This matters because endometrial cancer is the fourth most common cancer in UK women, and black women are twice as likely to die from it as white women. The current diagnostic pathway relies on transvaginal ultrasound, which is not specific enough: only 3% of women with abnormal bleeding who are referred for urgent investigation actually have cancer. The rest undergo unnecessary hospital visits and painful hysteroscopies, while clinics are overwhelmed and delays of three to six months cause 24% to 43% additional deaths each year. The WID-easy test detects DNA methylation markers in a self-collected sample, and early data suggest it outperforms ultrasound, including in black women. This project will test its feasibility in 2,000 NHS patients, assess staff and patient acceptance, and generate health economic data to support NICE guidance. If successful, the test could speed up diagnosis, reduce health inequalities, and free up hospital capacity—quietly improving a diagnostic pathway that currently fails both patients and the system.
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Background Endometrial cancer (EC) is the fourth most common cancer in women in the UK and its incidence is rising due to increasing overweight/obesity and longer life expectancies. Data from the UK and US indicate that black women are twice as likely to die from EC compared with white women. Abnormal Uterine bleeding (AUB) is the most common symptom of EC. More than 90% of people with EC present with AUB, yet only 3% of peri-/post-menopausal patients with AUB are eventually diagnosed with the disease. Challenges with diagnosis include the insufficient specificity of transvaginal ultrasound, which means that many women without cancer are referred for hysteroscopy and biopsy. Clinics are overwhelmed and cannot readily identify those who need urgent examinations. Three to six month delays in diagnosis lead to 24% to 43% additional deaths from EC each year. Sola Diagnostics WID-easy test is a novel aid to diagnosis that detects EC in a cervicovaginal sample. It is a real-time PCR-based assay that detects DNA methylation in genetic alleles of ZSCAN12 and GYPC. In a prospective, consecutive cohort study the WID-easy test outperformed ultrasound in the detection of EC. Additional data confirm WID-easy performance in black women. Implementing the WID-easy in the NHS could speed up and ensure earlier EC diagnoses, reduce health inequalities, reduce costs, and improve patient experience. Research question Is implementation of the WID-easy test in the NHS feasible and cost effective? Aims and Objectives This project aims to deliver the information that will be required to support NICE guideline development and therefore rapid implementation of the WID-easy test across the NHS. Its objectives are: To deliver data on feasibility of delivering the WID-easy test in real-world settings in the NHS. To identify patient and staff-related acceptance/barriers to adoption of the test in secondary and primary care settings. To generate initial health economic data to support guideline development by NICE. Methods Data will be generated in a prospective, interventional cohort study with a paired screen positive design in 2,000 women aged 45 years and over referred for evaluation of AUB. Recruitment to the study will take approximately 10 months. Outcomes will be reported 3 and 12 months after recruitment finishes. A comprehensive evaluation programme and complementary PPIE plan will ensure that the study and future NHS implementation plans for primary and secondary care are fit for purpose and acceptable to people from different backgrounds, including those typically underrepresented in research. Anticipated Impact Reporting of initial results from the EASY-CARE study 3 months after close of recruitment will accelerate discussions with the NHS and support wider implementation. Anticipated impacts include: Reductions of up to 88% Urgent Suspected Cancer referrals for AUB. Improve patient experience thanks to fewer unnecessary referrals, fewer hospital visits, reduced anxiety and fewer painful hysteroscopies. Identify more cases of EC earlier than the current standard of care. Reduce health inequality by improving the diagnostic pathway for black women. An extensive dataset, including health economics, patient and staff acceptability, to support WID-easy implementation in primary care.
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