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Self-collected first-void urine cytology as a non-invasive triage tool for endometrial cancer detection

Year: 2026

Type: article

Abstract: Introduction Sequential tests that measure, visualise and sample the endometrium are currently used to confirm disease status in women with suspected endometrial cancer. These tests are invasive and unpleasant, with moderate diagnostic accuracy. A non-invasive test that accurately triages women with postmenopausal bleeding (PMB) for routine diagnostics would improve patient care. The aim of this study was to measure the potential for self-collected first-void urine cytology to detect endometrial cancer in women with PMB. Methods This was a prospective diagnostic accuracy study of women referred with suspected endometrial cancer to St Mary’s Hospital in Manchester. Self-collected first-void urine (10 mL Colli-Pee ™ device with preservative for the first 94 participants, 20 mL with preservative thereafter) and clinician-collected vaginal samples (Delphi screener) were obtained prior to routine diagnostics. Cytology was evaluated by a cytologist blinded to participant disease status. The primary outcome was the sensitivity, specificity and accuracy of self-collected first-void urine cytology compared to vaginal cytology for endometrial cancer detection. Endometrial histopathology was the reference standard when performed; disease-negative status was defined by discharge from the cancer exclusion pathway and no cancer diagnosis at 6 months’ follow up. Results In 200 women with PMB (102 endometrial cancer cases; 98 cancer-free controls), self-collected first-void urine cytology demonstrated a sensitivity of 73.3% (95% CI 63.5-81.6) and specificity of 90.7% (95% CI 83.1-95.7) for endometrial cancer detection, with an AUC of 0.85 (95% CI 0.80-0.89). Vaginal cytology showed higher sensitivity 92.2% (95% CI 85.1–96.6), lower specificity 84.4% (95% CI 75.5–91.0) and an AUC of 0.94 (95% CI 0.91-0.97). Agreement between urine and vaginal cytology was substantial (κ=0.70), with discordant results predominantly in low-risk tumours. Urine cytology had good sensitivity in high-risk disease and remained a strong independent predictor of endometrial cancer on multivariable analysis (adjusted OR 23.8). In an exploratory but underpowered comparison, increasing Colli-Pee ™ device collection volume from 10 mL to 20 mL increased sensitivity (70% vs 74.6%, p=0.629). Discussion Self-collected first-void urine cytology shows moderate sensitivity and high specificity for endometrial cancer detection, however its diagnostic accuracy is currently insufficiently high to recommend its clinical use as a ‘rule-out’ triage tool. The practical advantage of the Colli-Pee ™ device, including its suitability for community-based self-collection, supports its potential role as a non-invasive sampling tool for women with suspected endometrial cancer, but more research is needed.

Source: Frontiers in Oncology

DOI: 10.3389/fonc.2026.1910651

Authors: Jean-Ellen Johnson, Nadira Narine, Aditi R. Chandraya, Helena O’Flynn, Molly Dore, Emma J. Davidson