Comparing digital and manual methods for cervical cancer screening
Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopic Approach
Hologic Deutschland GmbH · NCT04965857
This study tests whether a new digital method for cervical cancer screening works better than the traditional manual method to help detect cervical cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 35 Years to 90 Years |
| Sex | Female |
| Sponsor | Hologic Deutschland GmbH (industry) |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT04965857 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical performance of the Hologic Genius Digital Diagnostics System against the traditional liquid-based cytology (LBC) manual microscopy for cervical cancer screening. It involves the prospective analysis of ThinPrep slides collected during the German Co-Screening Program, which are routinely sent to a laboratory for examination. The study focuses on quality assurance by reviewing anonymized results from both diagnostic methods to determine their effectiveness in detecting cervical cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are women who have undergone cervical cancer screening with LBC ThinPrep samples collected by gynecologists as part of the German Cervical Cancer Screening Program.
Not a fit: Patients who have not participated in the German Cervical Cancer Screening Program or those with samples not collected using the LBC ThinPrep method may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and efficiency of cervical cancer screening, potentially leading to earlier detection and better patient outcomes.
How similar studies have performed: Other studies have shown promising results with digital cytology approaches, indicating potential advancements in cervical cancer screening methodologies.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Düsseldorf
- Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum — Düsseldorf, Germany (RECRUITING)
Study contacts
- Study coordinator: Henrik Griesser, Prof. Dr.
- Email: info@zotzklimas.de
- Phone: +49 (0)221 940 505 840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Cancer Screening