Protocol for Cervical Cancer Screening FCM Feasibility Study in EU. Measurement of the cell proliferation status / detection of cervical lesions for rapid screening (high throughput) of Cervical Cancer with the LC-1000
Completed
- Conditions
- cervical cancer10038594
- Registration Number
- NL-OMON43409
- Lead Sponsor
- Sysmex Europe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
females older than 20 years who visit a gynaecologist for a cervical smear
Exclusion Criteria
females younger than 20 years, pregnant women, women who were deemed inappropriate by their gynecologist to participate in this study, and women who underwent cervical conisation* (or total hysterectomy). However, after a certain period (approx. 6 month) following cervical conisation, it*s possible to participate in this study at the discretion of the gynecologist.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The histology results from the routine cytology positive sample will be<br /><br>compared to the sensitivity of other tests (cytology, LC-1000 and HPV) (primary<br /><br>evaluation criteria). To verify the clinical screening performance of the FCM<br /><br>system (LC-1000), the cytology result of the routine cytology sample and the<br /><br>LC-1000 result will be compared, sensitivity and specificity for advanced<br /><br>cervical lesions (CIN2 lesions or higher stages) finally calculated (secondary<br /><br>evaluation criteria). </p><br>
- Secondary Outcome Measures
Name Time Method <p>none</p><br>