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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hologic's Genius Digital Diagnostics System | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide. |
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Inclusion Criteria:
Humans with a cervix.
As part of the German National Cancer Plan, women over the age of 35 years will be given a cotest comprising a Pap smear and an HPV test, every three years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CytoMol - MVZ für Zytologie und Molekularbiologie Frankfurt GbR | Frankfurt am Main | 60437 | Germany |
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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 |