CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection

Area of Science:

• Gynecology
• Oncology
• Infectious Diseases

Background:

• High-risk human papillomavirus (hr-HPV) is the primary cause of cervical cancer.
• Germany's cervical cancer screening participation rate is around 70%.
• Self-testing offers a potential strategy to improve screening uptake.

Purpose of the Study:

• To evaluate the clinical performance of hr-HPV self-sampling devices.
• To assess the sensitivity of self-collected samples for high-grade cervical intraepithelial neoplasia (CIN 2+).
• To compare self-sampling performance against clinician-taken smears.

Main Methods:

• An open prospective multicenter trial involving 65 patients referred for colposcopy.
• Evaluation of three CE-certified self-sampling devices (vaginal and first-void urine) with PCR-based hr-HPV testing.
• Clinician-taken cervical smears served as the reference standard, with histological results as the gold standard.

Main Results:

• All invasive cancer cases and over 90% of CIN 3 lesions were hr-HPV positive across all three self-collection devices.
• Self-sampling devices were reported as easy to use without difficulties.
• Hr-HPV testing of self-collected samples demonstrated high sensitivity for CIN 3+, comparable to clinician-taken smears.

Conclusions:

• Self-collection of vaginal or urine samples for hr-HPV testing is a viable option to increase cervical cancer screening participation.
• These methods are highly sensitive for detecting significant cervical lesions (CIN 3+).
• Self-sampling is well-accepted by patients due to its convenience and ease of use.