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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slides from the German Co-Screening program | 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. |
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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 Manual microscopic reading) will be constructed. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system. | 1 year | |
| 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. |
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Inclusion Criteria:
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As part of the German National Cancer Plan, women over the age of 35 years will be given a co-test comprising a Pap smear and an HPV test, every three years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrik Griesser, Prof. Dr. | Contact | +49 (0)221 940 505 840 | info@zotzklimas.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum | Recruiting | Düsseldorf | 40210 | Germany |
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| 1 year |
| 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 |