Long-term follow-up of ARTISTIC cervical screening trial cohort
Research type
Research Study
Full title
Long-term follow-up of ARTISTIC cervical screening trial cohort
IRAS ID
153311
Contact name
Julian Peto
Contact email
Sponsor organisation
London School of Hygiene & Tropical Medicine
Research summary
The ARTISTIC trial compared cytology with and without HPV testing among 24,510 women attending for routine cervical screening in 2001-04. This project is an epidemiological follow-up based on their history of HPV infection and cytological abnormality, irrespective of their initial random allocation. Over 60,000 HPV tests (HC2 with full HPV typing of those testing positive) were performed on routinely collected LBC (liquid-based cytology) cervical samples taken from entry up to September 2009, when the trial ended. We have published reports on baseline data, follow-up through 2 further screening rounds up to September 2009, and various other aspects (see protocol for references).
Women were followed to 2009 through the two local participating cytology laboratories for cytology and histology. We now propose to obtain complete cytological follow-up by linkage to NHS cervical screening call-recall records. It is no longer possible to achieve adequate follow-up locally, as subsequent cytology on most women in the cohort is now sent to other laboratories due to organisational changes in the Manchester region. In addition, a substantial proportion of the women have now moved from the Manchester area. The cohort is already flagged through national registrations for cervical cancer incidence and death.
Follow-up of the cohort until 2015 will extend median follow-up from 6 years to 12 years. This is important, as screening intervals of up to 6 years for younger women and 10 years for older women following a negative HPV test are now being considered.
This will be passive follow-up, with no further contact with the women in the cohort.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/0627
Date of REC Opinion
12 May 2014
REC opinion
Favourable Opinion