Extension of cervical sample collection in the ARTISTIC Trial cohort
Research type
Research Study
Full title
Extension of cervical sample collection in the ARTISTIC Trial cohort
IRAS ID
232814
Contact name
Julian Peto
Contact email
Sponsor organisation
London School of Hygiene and Tropical Medicine
Duration of Study in the UK
4 years, 8 months, 31 days
Research summary
The ARTISTIC Trial recruited 24,510 women attending for routine cervical screening in Greater Manchester in 2001-2003. All the cervical smears taken in Greater Manchester were also tested for HPV. Laboratory records with cytology results and also any histology records were collected. Women were invited to return for further routine smears after 3 years (round 2) and 6 years (round 3).\n\nSince the trial finished in 2009, the women have returned to routine screening. We are still following the women (without contact) through linkage to screening records held by the national screening programme and to national cancer registration data. \n\nMany ARTISTIC women still live in the Greater Manchester area and their cervical screening is processed by the Manchester Cytology Centre. This centre is one of the six sites in England which are piloting primary HPV screening.\n\nWe are proposing to collect further samples from ARTISTIC women who have undergone routine HPV testing as part of their standard NHS cervical screening. We estimate about 10,000 HPV tests among ARTISTIC women will be done between 2017 and 2021 in the Manchester Cytology Centre. \n\nWe propose to collect and store left-over samples which would have been thrown away after routine HPV testing. This means that the care of these women will not be affected in any way. The positive samples will be genotyped, and the residual samples will be stored for future research on new tests. It is not practical to gain explicit consent from the participants in ARTISTIC as we will only know they have attended for screening once their sample has been tested in the laboratory. All results will be stored on a secure computer by a trial number without names or other personal information.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1483
Date of REC Opinion
18 Sep 2017
REC opinion
Favourable Opinion