Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System
1 other identifier
observational
1,994
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedStudy Start
First participant enrolled
August 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 15, 2022
August 1, 2021
1 month
August 3, 2021
April 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.
3 months
Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.
3 months
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory CytoMol as part of the German Cervical cancer screening program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CytoMol - MVZ für Zytologie und Molekularbiologie Frankfurt GbR
Frankfurt am Main, 60437, Germany
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2021
First Posted
August 11, 2021
Study Start
August 20, 2021
Primary Completion
September 27, 2021
Study Completion
December 31, 2021
Last Updated
April 15, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share