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ISRCTN
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ISRCTN25417821
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ClinicalTrials.gov identifier
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Public title
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A randomised trial of human papillomavirus (HPV) testing in primary cervical screening
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Scientific title
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Acronym
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ARTISTIC
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Serial number at source
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HTA 98/04/64; HTA 98/04/99
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration.
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Study design
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Pragmatic randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer (neoplasms): Cervix
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Participants - inclusion criteria
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Women aged 20-64 weighted by age bands to achieve a spread of HPV positives across the age range.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/06/2001
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Anticipated end date
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30/11/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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28,000 women
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Interventions
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Please note that, as of 14 January 2008, the anticipated start and end dates of this trial have been updated from 1 April 2000 and 31 March 2006 to 1 June 2001 and 30 November 2009, respectively.
Interventions:
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.
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Primary outcome measure(s)
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Reduction of high and low grade smears in the HPV revealed arm, at the next screening round. The difference in psychological and psychosexual outcomes in the HPV revealed arm as a consequence of knowledge of the HPV test result. 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).
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Henry C
Kitchener
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Address
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Academic Unit of Obstetrics & Gynaecology Reproductive Healthcare
University of Manchester
St Mary's Hospital
Whitworth Park
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City/town
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Manchester
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Zip/Postcode
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M13 0JH
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Country
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United Kingdom
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Tel
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+44 (0)161 276 6646
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Fax
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+44 (0)161 276 6134
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Email
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henry.kitchener@cmmc.nhs.uk
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Sponsor
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University of Manchester (UK)
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Address
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Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Sponsor website:
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http://www.manchester.ac.uk/
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Date applied
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25/04/2003
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Last edited
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18/07/2008
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Date ISRCTN assigned
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25/04/2003
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