Cervical Neoplasia Cancer Cervical
Conditions
Interventions
Comparison of the results of manually read cervical cytology slides with those using automated technology
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 100,000 women undergoing primary cervical screening
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 03/02/2009: The relative sensitivity of screening by automated or manually read cytology to detect CIN3/invasive cancer (CIN3+) and CIN2, 3 and invasive cancer (CIN2+). | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 03/02/2009: Clinical outcomes: 1. The detection rates of CIN2+ and ICN3+ in each arm 2. The detection rates (positive predictive values) for each category of cytology including the threshold of borderline or greater and mild dyskaryosis or greater 3. Relative specificity rates of screening by automated and manual reading 4. All of the above comparing Focal Point™ and Imager™ 5. The reliability of no further review in Focal Point™ in terms of negative predictive value using negative manual reading in the paired reading and the reference standard 6. To assess inadequate rates with both technologies Economics and organisational outcomes: 7. Comparative throughput and reporting times (for each stage of screening) 8. Detailed cost estimate of the total cost of processing smear at the laboratory and total cost per smear including consideration of inadequate rates and using no further review at different cut off-levels 9. Estimate of the comparative cost effectiveness of automated versus manually read cytology using trial data and modelled lifetime costs and effects 10. Assessment of cytoscreeners' experience and satisfaction with automated systems and the organisational changes that automation would require in implementation | — |
Countries
England, United Kingdom
Outcome results
None listed