ISRCTN - ISRCTN66377374: A comparison of automated technology and manual cervical screening

Plain English Summary

http://cancerhelp.cancerresearchuk.org/trials/a-trial-to-test-a-new-way-of-looking-at-cervical-smear-tests

Trial website

http://www.cancerhelp.org.uk/trials/trials/trial.asp?trialno=11269

Contact information

Type

Scientific

Primary contact

Prof Henry Kitchener

ORCID ID

Contact details

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
+44 (0)161 276 6461
henry.kitchener@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/04/02

Study information

Scientific title

A comparison of automated technology and manual cervical screening: a randomised controlled trial

Acronym

MAVARIC

Study hypothesis

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

Central Manchester Local Research Ethics Committee, approved on 08/12/2004 (ref: 04/Q1407/318)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cervical Neoplasia

Intervention

Comparison of the results of manually read cervical cytology slides with those using automated technology

Intervention type

Other

Phase

Not Applicable

Drug names

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 trial start date

01/08/2005

Overall trial end date

31/10/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

100,000 women undergoing primary cervical screening

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100,000 women

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/08/2005

Recruitment end date

31/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

Government

Website

http://www.manchester.ac.uk/

Funders

Funder type