Condition category
Cancer
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
07/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Henry C Kitchener

ORCID ID

Contact details

Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
University of Manchester
St Mary's Hospital
Whitworth Park
Manchester
M13 0JH
United Kingdom
+44 (0)161 276 6646
henry.c.kitchener@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 98/04/99; HTA 98/04/64

Study information

Scientific title

Acronym

ARTISTIC

Study hypothesis

1. To study a randomised population of women undergoing cytological screening in whom an HPV test result is revealed with a smaller cohort in whom the result is concealed.
2. To study the psychological and psychosexual differences between corresponding cytological groups in the two study arms.
3. To study the economic benefits or otherwise of HPV testing.
4. To study the predictive ability of HPV testing positive or negative in the presence of normal cytology in terms of future risk, and screening intervals.
5. To see if HPV testing achieves a more efficient protocol following "inadequate" smears and low grade smears.
6. To evaluate the relevance of viral persistence and load in predicting risk.
7. To evaluate sensitivity, specificity and negative predictive value of HPV testing.
8. To compare the results of different HPV testing methods in terms of objective 7 and also to examine interlaboratory variation.

More details can be found at: http://www.hta.ac.uk/1162
Protocol can be found at: http://www.ncchta.org/protocols/199800040064.pdf

Updated 14/01/2008: the anticipated start and end dates of this trial were updated from 01/04/2000 and 31/03/2006 to 01/06/2001 and 30/11/2009, respectively.

Updated 30/09/2013: the NIHR has awarded funding to extend the follow-up of this trial until 2015. This will be done by linkage with national screening and cancer registration records without recontacting patients.

Ethics approval

North West Multi-centre Research Ethics Committee, approved on 18/08/2000 (ref: MREC 00/8/30)

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Condition

Cervical cancer

Intervention

Women who are attending for cervical screening, all of whom will have a smear and an HPV test, will be individually randomised in a ratio of 3:1 to a study arm (HPV test revealed) and a control arm (HPV test concealed). The control arm will be managed by routine clinical practice as per national guidelines with a rescreen and HPV test at 3 years.

1. High grade smears (HPV +ve or -ve) - routine management (colposcopy)
2. Low grade smears (HPV +ve) - routine management (colposcopy)
3. Low grade smears (HPV -ve) - repeat smear at 6/12. If abnormal, colposcopy
4. Normal smears (HPV +ve) - repeat HPV test at 12/12. If persistent HPV +ve, patient choice between colposcopy and surveillance
5. Normal smears (HPV -ve) - rescreen at 36/12. Colposcope 500 volunteers to address true sensitivity.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Reduction of high and low grade smears in the HPV revealed arm, at the next screening round
2. The difference in psychological and psychosexual outcomes in the HPV revealed arm as a consequence of knowledge of the HPV test result
3. Cost: the number of women experiencing the cost generating events (cytology, HPV test, colposcopy, biopsy and treatment and ad hoc primary care consultations) will be identified and the associated unit costs will be estimated and attached to these events to determine total costs in each arm. Cost effectiveness will be presented as an incremental cost per additional high grade smear detected, and as an incremental cost per life year gained and per quality adjusted life year gained (estimated by extrapolating from the trial endpoint using modelling techniques).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 20-64 weighted by age bands to achieve a spread of HPV positives across the age range.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

28,000 women

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2001

Recruitment end date

01/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 main results in http://www.ncbi.nlm.nih.gov/pubmed/19540162
2009 results on cost effectiveness and psychosocial effects in http://www.ncbi.nlm.nih.gov/pubmed/19891902
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20007387
2011 extended follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/21334200
2014 extended follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/24762804

Publication citations

  1. Main results

    Kitchener HC, Almonte M, Thomson C, Wheeler P, Sargent A, Stoykova B, Gilham C, Baysson H, Roberts C, Dowie R, Desai M, Mather J, Bailey A, Turner A, Moss S, Peto J, HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial., Lancet Oncol., 2009, 10, 7, 672-682, doi: 10.1016/S1470-2045(09)70156-1.

  2. Protocol

    Sargent A, Bailey A, Turner A, Almonte M, Gilham C, Baysson H, Peto J, Roberts C, Thomson C, Desai M, Mather J, Kitchener H, Optimal threshold for a positive hybrid capture 2 test for detection of human papillomavirus: data from the ARTISTIC trial., J. Clin. Microbiol., 2010, 48, 2, 554-558, doi: 10.1128/JCM.00896-09.

  3. Kitchener HC, Almonte M, Gilham C, Dowie R, Stoykova B, Sargent A, Roberts C, Desai M, Peto J, , ARTISTIC: a randomised trial of human papillomavirus (HPV) testing in primary cervical screening., Health Technol Assess, 2009, 13, 51, 1-150, iii-iv, doi: 10.3310/hta13510.

  4. Kitchener HC, Gilham C, Sargent A, Bailey A, Albrow R, Roberts C, Desai M, Mather J, Turner A, Moss S, Peto J, A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: extended follow up in the ARTISTIC trial., Eur. J. Cancer, 2011, 47, 6, 864-871, doi: 10.1016/j.ejca.2011.01.008.

  5. C Kitchener H, Canfell K, Gilham C, Sargent A, Roberts C, Desai M, Peto J, The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds., Health Technol Assess, 2014, 18, 23, 1-196, doi: 10.3310/hta18230.

Additional files

Editorial Notes