Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy

July 3, 2023 updated by: Hologic Deutschland GmbH

Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopic Approach

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

Study Overview

Status

Recruiting

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 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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Henrik Griesser, Prof. Dr.
  • Phone Number: +49 (0)221 940 505 840
  • Email: info@zotzklimas.de

Study Locations

  • Germany
      • Düsseldorf, Germany, 40210
        • Recruiting
        • Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum
        • Contact:
          • Henrik Griesser, Prof. Dr.
          • Phone Number: +49 (0)221 940 505 840
          • Email: info@zotzklimas.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz & Klimas as part of the German Cervical cancer screening program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Hologic's Genius Digital Diagnostics 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: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system.
Time Frame: 1 year
1 year
Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.
Time Frame: 1 year
To assess the impact on the workflow of the introduction of a Digital Cytology procedure to a high-throughput screening lab in Germany.
1 year
Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic Deutschland GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTS1650_20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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