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NCT04965857 Clinical Trial

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

Cervical Cancer Screening Clinical Trial

Official title:
Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopic Approach

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04965857
Other study ID # BTS1650_20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2023

Study information
Verified date July 2023
Source Hologic Deutschland GmbH
Contact Henrik Griesser, Prof. Dr.
Phone +49 (0)221 940 505 840
Email info@zotzklimas.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender Female
Age group 35 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Hologic's Genius Digital Diagnostics System
Genius Digital Diagnostics is a digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

Locations
Country Name City State
Germany Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum Düsseldorf

Sponsors (1)
Lead Sponsor Collaborator
Hologic Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner. 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. 1 year
Secondary To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system. 1 year
Secondary Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner. To assess the impact on the workflow of the introduction of a Digital Cytology procedure to a high-throughput screening lab in Germany. 1 year
Secondary Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide. 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. 1 year
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