Details of HTA project
Last updated: 1 February 2012 - Next update due: 8 February 2012
Research type: |
Primary Research (e.g. trial) |
Project title: |
A randomised trial of human papilloma virus testing in primary cervical screening (ARTISTIC) |
Special notes |
This is a continuation of project 98/04/64. |
Project ref: |
98/04/99 |
Cost: |
£276,915 |
Chief Investigator : |
Professor Henry Charles Kitchener, Professor of Gynaecological Oncology, Academic Unit of Obstetrics and Gynaecology, University of Manchester |
Start Date: |
April 2008 |
Estimated date of publication in HTA journal series: |
February 2013. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed. |
Plain English Summary |
The aim of this project is determine whether testing for human papillomavirus HPV in the cervix adds effectiveness to cervical screening programme. This currently relies on cervical smears, which is estimated to prevent around 70% of cancers by detecting precancers which are easily treated. Previous research has indicated that HPV testing will pick up some lesions that smears miss. The design of the project is a trial involving 25,000 women who have undergone routine cervical screening. After giving signed consent women who were screened also had an HPV test on the cervical cells and in a ration of 3:1 were randomly allocated to the HPV result being revealed or concealed to both women and trial investigators. Women in the revealed arm who were HPV positive with a negative smear underwent repeat testing at 12 months and colposcopy offered if still positive. All of the women are being screened after 3 years and the main aim is to determine whether as a result of the HPV testing the revealed arm have few precancers at the 3 year follow-up because of improved detection previously. Another important objective is to determine what psychological impact HPB testing had, given that it is sexually transmitted and may make women feel anxious or stigmatised. The third key outcome is to determine whether HPV testing is cost effective, i.e. whether the additional cost of the test is satisfied by higher detection rates or has the potential to save other costs in the programme. Some results from the first round of screening will be published in 2005 together with the psychological data. The final results will be published in 2007. |
Project Abstract: |
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, and as a stand alone test. 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. |
ISRCTN* number: | ISRCTN 25417821 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN25417821 |
Project Protocol: |
Project protocol not available |
URL of this page: |
http://www.hta.ac.uk/1710 |
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