Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System
Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System - a Retrospective Assessment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Frankfurt am Main, Germany, 60437
- CytoMol - MVZ für Zytologie und Molekularbiologie Frankfurt GbR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner
Time Frame: 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.
Time Frame: 3 months
|
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.
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTS1702_21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.