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NCT Number: NCT05000125

Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System

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).

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Key information

Conditions

Cervical Cancer Screening

Age range

35 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

CytoMol - MVZ für Zytologie und Molekularbiologie Frankfurt GbR

Frankfurt am Main, 60437, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hologic Deutschland GmbH

Industry

Registry information

Official study title

Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System - a Retrospective Assessment

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2021
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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