Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy
1 other identifier
observational
3,000
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Typical duration 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
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 5, 2023
July 1, 2023
2.3 years
June 16, 2021
July 3, 2023
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 Manual microscopic reading) will be constructed.
1 year
Secondary Outcomes (3)
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.
1 year
Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.
1 year
Study Arms (1)
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.
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 co-test 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 Zotz \& Klimas as part of the German Cervical cancer screening program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum
Düsseldorf, 40210, Germany
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2021
First Posted
July 16, 2021
Study Start
September 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 5, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share