A comparison of automated technology and manual cervical screening
ISRCTN | ISRCTN66377374 |
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DOI | https://doi.org/10.1186/ISRCTN66377374 |
Secondary identifying numbers | HTA 03/04/02 |
- Submission date
- 11/01/2005
- Registration date
- 12/01/2005
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Henry Kitchener
Scientific
Scientific
Academic Unit of Obstetrics and Gynaecology
School of Cancer and Imaging Science
University of Manchester
St. Mary's Hospital
Hathersage Road
Manchester
M13 0JH
United Kingdom
Phone | +44 (0)161 276 6461 |
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henry.kitchener@manchester.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A comparison of automated technology and manual cervical screening: a randomised controlled trial |
Study acronym | MAVARIC |
Study objectives | Cervical screening by cytology (smear tests) has proven an effective means of reducing death rate from cervical cancer. Conventional smears (Pap tests) have probably achieved as much as they can in the UK. Some gains will be achieved by the introduction of a new type of sample, obtained by putting the sample into fluid rather than smeared on a slide. These include a reduction in inadequate smears and more rapid reading, both of which will achieve greater efficiency and convenience to women. Pressures on cytoscreeners will lessen. The use of automated technology may further these benefits by making identification of the abnormal cells easier. Instead of scanning an entire slide the cytoscreeners will be directed to 15-22 locations on a slide by the computerised software. In addition, one of the machines (Focal Point) can sort the abnormal slides into quintiles. In addition, 20-25% are classified as 'no further review' meaning that manual reading is not required. In order to assess these potential benefits, tight and unbiased comparisons with manual (current) reading are required. This will ensure that women can expect the most accurate and reliable screeing service, which is as cost effective as possible. To be convincing, this type of study needs to be embedded in the NHS Cervical Screening Programme. Finally human papillomavirus testing is undergoing evaluation internationally as a means of increasing sensitivity of screening (including a Health Technology Assessment Programme funded trial in Manchester). We will use HPV testing to indicate which women with the least abnormal grades of cytology require colposcopy. Trial details are also available at: http://www.hta.ac.uk/1462 Protocol can be found at: http://www.hta.ac.uk/protocols/200300040002.pdf Please note that the scientific title was added to this trial record as of 03/02/2009. |
Ethics approval(s) | Central Manchester Local Research Ethics Committee, approved on 08/12/2004 (ref: 04/Q1407/318) |
Health condition(s) or problem(s) studied | Cervical Neoplasia |
Intervention | Comparison of the results of manually read cervical cytology slides with those using automated technology |
Intervention type | Other |
Primary outcome measure | 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 outcome measures | 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 |
Overall study start date | 01/08/2005 |
Completion date | 31/10/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 100,000 women |
Total final enrolment | 73266 |
Key inclusion criteria | 100,000 women undergoing primary cervical screening |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/08/2005 |
Date of final enrolment | 31/10/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of Obstetrics and Gynaecology
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Sponsor information
University of Manchester (UK)
Government
Government
Oxford Road
Manchester
M13 9PL
United Kingdom
Website | http://www.manchester.ac.uk/ |
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https://ror.org/027m9bs27 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/01/2011 | Yes | No | |
Results article | results | 01/01/2011 | Yes | No | |
Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.