Scottish HPV Investigators' Network (SHINe) - University of Edinburgh

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surveillance not as clinical samples; experimental work was limited to samples with mono infections (only 10%) hence HPA’s interest in Scottish archive Updates on CSO Programmes HAC reported on progress with the BTRC award in relation to facilities, staffing, samples in archive, approvals and research. A copy of her presentation slides was circulated MC updated on position with HSR project and introduced Seonaidh Cotton as Programme coordinator. She commented that central to the HSR programme was the modelling of future screening policy and CR explained the model of cost effectiveness which had been developed with HPA and input from Dublin as a generic model of HPV transmission and vaccine impact, regionalised according to screening policies. ED commented that cytology was not a stationary target due to the feasibility studies of automated imaging. After vaccination the sensitivity of cytology would plummet and the Imager system might help restore this but the timescale of adoption is unknown. It was pointed out that the feasibility study was to study practicalities of transporting samples to a few reference centres, not the value of automated reading. The Scottish report and the HTA Mavaric study report will both become public in the first part of 2010. MC reminded the group of the research projects in the programme and highlighted that the REC approval was almost through for HPV genotyping of women aged 20-24 attending colposcopy as result of abnormal smear. A student in Aberdeen would set up processes during December with first women enrolled in Aberdeen in January 2010. These samples are an important contribution to the archive as they will be fully genotyped. Construction of the National Archive KC outlined the intention for 50,000 samples or 25,000 with two aliquots and highlighted the need to populate the archive sensibly rather than simply filling up the bank. Her calculations showed that with LBC surveillance and HSR projects there would be around 13,800 samples over 4 years of which 5,500 would have genotyping through surveillance. With two aliquots per sample this would fill half the archive. If all LBC from 1 st attenders were collected each year (c3000 pa) this would rise to 22,800. The storage of cell suspensions and NA extracts at -80 0 C were both reasonable approaches and a small study of LBC samples collected in 2000 and retested in 2008 gave 91% full or partial concordance for DNA. CR gave some idea of the sample sizes relevant for adequate powering of research questions and pointed out that small numbers will be required to show significant changes in HPV 16/18 prevalence due to impact of vaccine while showing changes in any other types will require large numbers. Having an adequate baseline sample was crucial. SB commented that it seemed inappropriate to have a large archive when many of the samples would be negative and the collection should be enriched for positives by concentrating on patients with recognisable disease. HAC commented that this would be dependent on clinical data available after sample had been received. It was agreed that the sample collection was dynamic and the need to cull on a regular basis should be built in to protocols. In the absence of better information, it was agreed that 2 aliquots (cells and NA extract which could preserve RNA as well as DNA) should be stored. In relation to biopsy samples, it was suggested that the 500 collected every second year for surveillance should be complemented by 500 non-surveillance samples in intervening years. The two storage samples should be an additional section and NA extract. HAC suggested that storing an additional section on a glass slide might be preferable to a section in an eppendorf as it would allow microdissection and/or immunostaining. In relation to consents, RA commented that use of national archives was an important part of Better Cancer care and as this archive was at the pre-cancer end it should be considered similarly to other cancer archives. There is considerable activity through Scottish Academic Health Sciences Collaboration to have consent which completely covered use of ‘residual or
surplus’ diagnostic sample for research. In GGHB a new policy will apply to all tissues/ samples including blood with information going to SCI store to be shared for research purposes. These are dramatic changes and she agreed to pass on information. FS offered to send appropriate wording from UK Biobank collection. HPV Surveillance in Scotland KS reported on the HPS strategy for surveillance starting with vaccine uptake data which showed that school programme had reached over 90% in all age groups with out-of school less than half of that. However it was noted that latter started later, had a large back-log of data entry and had been more affected by H1N1. In schools uptake was over 80% across all deprivation index quintiles and across the age range. She reported on the HPV positivity in all surveillance arms with urine prevalence study in teenagers showing 25% positivity in 17-18 year old girls and 5% in males (c/f HPA results of 40% in urine in women and 10% in men check) KS also talked of approval for the linkage of CHI numbers to both CHSP-S vaccine data and in time SCCRS cytology data. This approval was obtained not through PAC but through the CHI Advisory group (Caldicott guardians plus others). No group would have all data on named individuals. The link would be made once per year, probably in March with first linkage in March 2011 after a small number of the girls entering screening would have been vaccinated. Current/Near Future of Cervical screening Isabel Gavin provided an extremely useful insight into the position and potential changes to the screening programme. She outlined the Test of Cure Early Implementers project using ‘PreQuot’ LBC sample and HPV testing at 6,12 and 24 months. NHS Highland had informally agreed and NHS Lothian formally responded but as process was again to test transport this would not happen by using Lothian! However it will also test the HPV Module of SCCRS which is essential for future changes to the programme. This specification for the module has been written and funding found for the software development which will take approx 6 months from unknown starting point. IG talked of activity in the Information Advisory Group following exploration of attitudes to low uptake and the need to improve communication strategy in relation to screening. New leaflets are in development and both SGPC and SHPVRL would be co-opted to comment before publication. SG asked how the information will be linked to websites and comments were made by several present that an easy source of information which is first hit on Google (Just as www.fightcervicalcancer.org.uk was) is required. Finally IG reported on the position with age of screening. When England increased the starting age of programme from 20 to 25, Scotland’s NAG decided that no changes would be made in Scotland until LBC evaluation, full SCCRS implementation and more evidence on value of HPV testing had been published and agreed to review the situation in 2010 with decision within 1 year. The draft scope had already gone to NAG, noting that Peter Sasieni had said there was insufficient evidence in England to lower starting age and no evidence in Scotland to increase it! ED asked what other evidence was required not to consider HPV first instead of cytology. IG replied that the draft scope did not contain any reference to this, nor to impact of HPV vaccination on the decision, nor to awareness of impact of any age changes on the surveillance strategy in place and the consequent programmes of research, also funded by Scottish Government. The group was particularly concerned with this lack of joined-up thinking and it was agreed that IG would feed back on all of these concerns. HPV late mRNA expression SG reported on the CSO project grant she had which was the first to use samples which could be part of the archive. A pilot study of 8 HPV 16 LBC samples had suggested that late mRNA expression was preferentially detected in low grade disease with E6/E7 oncogene expression found at higher levels in high grade disease. Her group was extending this to 60 HPV16 mono-
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Scottish HPV Investigators' Network (SHINe) - University of Edinburgh

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