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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1994 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-20

Study Completion Date

2021-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cervical Cancer Screening

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Slides from the German Co-Screening program

From 32506 LBC slides (ThinPrep, Hologic Inc., USA) from the German Co-screening program measured in 2020 with the TIS all abnormal findings according to Munich III groups (II-p - V) and 3% of normal slides (Munich III groups (I+II-a)) will be selected for the additional measurement with the Genius Digital cytology system.

Hologic's Genius Digital Diagnostics System

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes