Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy

Recruiting

• Conditions: Cervical Cancer Screening
• Interventions: Diagnostic Test: Hologic's Genius Digital Diagnostics System

• Registration Number: NCT04965857
• Lead Sponsor: Hologic Deutschland GmbH

Brief Summary

Quality assurance of the laboratory examinations. Prospective non-interventional study with ThinPrep slides collected during the German Co-Screening Program and routinely sent to the lab to prospectively evaluate the clinical performance of the Hologic Genius Digital Cytology (DC) system vs. the liquid-based cytology (LBC) manual microscopic approach

Detailed Description

The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to prospectively evaluate the Hologic Genius Digital Cytology (DC) system in the lab, selected routinely screened and already archived slides will be additionally reviewed with the liquid-based cytology (LBC) manual microscopic approach. Only anonymized results will be evaluated.

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-16
• Study Start: 2021-09-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

• LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz & Klimas as part of the German Cervical cancer screening program.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Slides from the German Co-Screening program	Hologic's Genius Digital Diagnostics System	From 25,000 LBC slides (ThisPrep, Hologic Inc., USA) from the German Co-screening program evaluated using the Genius Digital cytology system all abnormal findings according to Munich III groups (II-p - V) and each 10th normal slide (Munich III group I and II) will be selected for the prospective evaluation by manual microscopy.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner.	1 year	To demonstrate non-inferiority, the appropriate approximative one-sided 95% confidence interval for the true difference between the two approaches (Digital Cytology and Manual microscopic reading) will be constructed.

Secondary Outcome Measures

Name	Time	Method
Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.	1 year	To assess the impact on the workflow of the introduction of a Digital Cytology procedure to a high-throughput screening lab in Germany.
Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.	1 year	The performance of Hologic Genius Digital Cytology Imaging scanner during cervical cancer screening (using histology as reference method) will be assessed via sensitivity, specificity, positive and negative predictive values.
To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system.	1 year

Trial Locations

Locations (1)

Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum; 🇩🇪 Düsseldorf, Germany