Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System

Cervical Cancer Screening Clinical Trial

Official title:

Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System - a Retrospective Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000125
• Other study ID #: BTS1702_21
• Status: Completed
• Start date: August 20, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Hologic Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Quality assurance of the laboratory examinations. Retrospective non-interventional study with ThinPrep slides collected as part of the German Co-Screening Program for routine diagnostic. These slides will retrospectively be used to validate the Hologic Genius Digital Cytology (DC) system vs. the ThinPrep Imaging system (TIS).

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 retrospectively validate the Hologic Genius Digital Cytology (DC) system selected slides earlier measured with TIS will be additionally reviewed with the Genius Digital Diagnostic System in order to demonstrate clinical performance and efficiency. Hologic's Digital Image Analysis Algorithm uses AI to identify diagnostically relevant objects of interest.Only anonymized results will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1994
• Est. completion date: December 31, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: 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 CytoMol as part of the German Cervical cancer screening program.

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

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	CytoMol - MVZ für Zytologie und Molekularbiologie Frankfurt GbR	Frankfurt am Main

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 the ThinPrep Imaging system (TIS)) will be constructed.	3 months
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.	3 months
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.	3 months