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

Hologic

Status: Enrolling

Conditions: Cervical Cancer Screening

Treatments: Diagnostic Test: Hologic's Genius Digital Diagnostics System

Study type: Observational

Funder types: Industry

Identifiers

NCT04965857

BTS1650_20

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 35 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

3,000 participants in 1 patient group

Slides from the German Co-Screening program

Description:

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.

Treatment:

Diagnostic Test: Hologic's Genius Digital Diagnostics System