Cervical Cancer ScreeningNCT04965857
Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy
An observational study of Cervical Cancer Screening, run by Hologic Deutschland GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 90 years, women only
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Hologic's Genius Digital Diagnostics System
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz \& Klimas as part of the German Cervical cancer screening program.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum
Düsseldorf, 40210
Henrik Griesser, Prof. Dr., +49 (0)221 940 505 840, info@zotzklimas.de
About this study
Official title: 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
Read the 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.
- Conditions
- Cervical Cancer Screening
- Being tested
- Hologic's Genius Digital Diagnostics System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hologic's Genius Digital Diagnostics SystemDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Hologic's Genius Digital Diagnostics System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system.
Measured: 1 year
Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.
To assess the impact on the workflow of the introduction of a Digital Cytology procedure to a high-throughput screening lab in Germany.
Measured: 1 year
Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hologic Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965857
- Sponsor's protocol ID
- BTS1650_20
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopic Approach
- ClinicalTrials.gov ID
- NCT04965857
- Acronym / sponsor ID
- BTS1650_20
- Conditions
- Cervical Cancer Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Hologic Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slides from the German Co-Screening program | – | Diagnostic Test: Hologic's Genius Digital Diagnostics SystemFrom 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. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz \& Klimas as part of the German Cervical cancer screening program.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hologic's Genius Digital Diagnostics SystemGenius 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. | Diagnostic test | Slides from the German Co-Screening program |
Primary outcome
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.
3 secondary outcomes
To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system.
Time frame: 1 year
Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.
Time frame: 1 year
Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Screening, run by Hologic Deutschland GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrik Griesser, Prof. Dr. (+49 (0)221 940 505 840, info@zotzklimas.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.