A comparison of automated technology and manual cervical screening

ISRCTN ISRCTN66377374
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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-to-test-a-new-way-of-looking-at-cervical-smear-tests

Study website

Contact information

Prof Henry Kitchener
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
Email henry.kitchener@manchester.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA comparison of automated technology and manual cervical screening: a randomised controlled trial
Study acronymMAVARIC
Study objectivesCervical 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) studiedCervical Neoplasia
InterventionComparison of the results of manually read cervical cytology slides with those using automated technology
Intervention typeOther
Primary outcome measureAdded 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 measuresAdded 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 date01/08/2005
Completion date31/10/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants100,000 women
Total final enrolment73266
Key inclusion criteria100,000 women undergoing primary cervical screening
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/08/2005
Date of final enrolment31/10/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Unit of Obstetrics and Gynaecology
Manchester
M13 0JH
United Kingdom

Sponsor information

University of Manchester (UK)
Government

Oxford Road
Manchester
M13 9PL
United Kingdom

Website http://www.manchester.ac.uk/
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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.