A comparison of automated technology and manual cervical screening

ISRCTN	ISRCTN66377374
DOI	https://doi.org/10.1186/ISRCTN66377374
Protocol serial number	HTA 03/04/02
Sponsor	University of Manchester (UK)
Funder	Health Technology Assessment Programme

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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+).
Key secondary outcome measure(s)	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
Completion date	31/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	100000
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

United Kingdom
England

Study participating centre

Academic Unit of Obstetrics and Gynaecology

Manchester
M13 0JH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.