Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial.

Objective: To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices.

Design: Randomised controlled trial.

Setting: St Mary's Hospital, Manchester, UK.

Staged design recommendations for validating relative sensitivity of self-sample human papillomavirus tests for cervical screening.

Objectives: To ensure that the emerging methods for human papillomavirus (HPV) testing on self-collected samples in cervical screening are evaluated robustly.

Study Design And Setting: We assess paired study designs for relative sensitivity of self-collected vs. traditional clinician-collected samples in detection of high-grade cervical intraepithelial neoplasia.

A comparison of the carbon footprint of alternative sampling approaches for cervical screening in the UK: A descriptive study.

Objective: To understand whether self-sampling can reduce carbon emissions (CO e) from the NHS cervical screening programme (NHSCSP) by comparing the carbon footprint of three sampling strategies: routine cervical sampling, vaginal self-sampling and first-void (FV) urine collection.

Design: Descriptive study.

Setting: National Health Service (NHS), United Kingdom (UK).

Long-term risks of invasive cervical cancer following HPV infection: follow-up of two screening cohorts in Manchester.

Background: Long-term follow-up of large cohorts is needed to determine the effects of HPV and screening on CIN3 (grade 3 cervical intraepithelial neoplasia) and ICC (invasive cervical cancer).

Methods: Women were recruited when attending for routine cervical screening in Greater Manchester, UK: 1987-93 for the Manchester Cohort (MC: 47,625 women) and 2001-03 for the ARTISTIC Cohort (AC: 24,496 women). Both were followed through national registration for cancer incidence and mortality to 2020.

Widening the offer of human papillomavirus self-sampling to all women eligible for cervical screening: Make haste slowly.

Self-collection of samples for human papillomavirus (HPV) testing has the potential to increase the uptake of cervical screening among underscreened women and will likely form a crucial part of the WHO's strategy to eliminate cervical cancer by 2030. In high-income countries with long-standing, organised cervical screening programmes, self-collection is increasingly becoming available as a routine offer for women regardless of their screening histories, including under- and well-screened women. For these contexts, a validated microsimulation model determined that adding self-collection to clinician collection is likely to be cost-effective on the condition that it meets specific thresholds relating to (1) uptake and (2) sensitivity for the detection of high-grade cervical intraepithelial neoplasia (CIN2+).

16/18 genotyping in triage of persistent human papillomavirus infections with negative cytology in the English cervical screening pilot.

Background: In the English pilot of primary cervical screening with high-risk human papillomavirus (HR-HPV), we exploited natural viral clearance over 24 months to minimise unnecessary referral of HR-HPV+ women with negative cytology. Three laboratories were permitted to use 16/18 genotyping to select women for referral at 12-month recall. We estimated the clinical impact of this early genotyping referral.

HPV testing compared with routine cytology in cervical screening: long-term follow-up of ARTISTIC RCT.

Background: The National Screening Committee (NSC) based its recommendation that human papillomavirus (HPV) testing should replace cytology in primary cervical screening largely on the 2009 follow-up results of the ARTISTIC trial (A Randomised Trial In Screening To Improve Cytology). The NSC must now decide on screening intervals and triage policy. Options include extending the screening interval up to 10 years for human papillomavirus-negative (HPV-) women, delaying recall for human papillomavirus-positive (HPV+) women with normal cytology (as their infections are usually transient), and basing triage on full HPV typing.

Improving laboratory workflow through automated pre-processing of SurePath specimens for human papillomavirus testing with the Abbott RealTime assay.

Background: Cervical specimens collected in liquid-based cytology (LBC) are used for cervical screening in the UK. The Abbott RealTime high-risk human papillomavirus (hrHPV) assay for the detection of 14 hrHPV types is approved by the English NHS Cervical Screening Programme (NHSCSP). As per manufacturer's instructions, pre-analytic processing of LBC involves a manual vortex and liquid transfer into a secondary tube.

Primary cervical screening with high risk human papillomavirus testing: observational study.

Objective: To provide the first report on the main outcomes from the prevalence and incidence rounds of a large pilot of routine primary high risk human papillomavirus (hrHPV) testing in England, compared with contemporaneous primary liquid based cytology screening.

Design: Observational study.

Setting: The English Cervical Screening Programme.

A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC).

Background: Falling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged < 35 years. Various barriers to screening have been documented, including fear, embarrassment and inconvenience.

Objectives: To measure the feasibility, clinical effectiveness and cost-effectiveness of a range of interventions to increase the uptake of cervical screening among young women.

Tumour suppressor gene methylation and cervical cell folate concentration are determinants of high-risk human papillomavirus persistence: a nested case control study.

Background: Persistent infection with one or more high-risk human papillomavirus [HR-HPV] types increases the risk of intraepithelial neoplasia and cervical cancer. A nested case-control study was conducted to investigate the importance of cervical cell folate concentration and tumour suppressor gene methylation as risk factors for HR-HPV persistence.

Methods: Cervical cell samples from 955 women with HR-HPV infection and normal, borderline or mild dyskaryosis were retrieved from the archive of a population-based screening trial.

The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds.

Background: The ARTISTIC (A Randomised Trial In Screening To Improve Cytology) trial originally reported after two rounds of primary cervical screening with human papillomavirus (HPV). Extended follow-up of the randomised trial cohort through a third round could provide valuable insight into the duration of protection of a negative HPV test, which could allow extended screening intervals. If HPV primary screening is to be considered in the national programme, then determining its cost-effectiveness is key, and a detailed economic analysis using ARTISTIC data is needed.

Epigenetic variability in cells of normal cytology is associated with the risk of future morphological transformation.

Background: Recently, it has been proposed that epigenetic variation may contribute to the risk of complex genetic diseases like cancer. We aimed to demonstrate that epigenetic changes in normal cells, collected years in advance of the first signs of morphological transformation, can predict the risk of such transformation.

Methods: We analyzed DNA methylation (DNAm) profiles of over 27,000 CpGs in cytologically normal cells of the uterine cervix from 152 women in a prospective nested case-control study.

The dynamics and prognostic potential of DNA methylation changes at stem cell gene loci in women's cancer.

Aberrant DNA methylation is an important cancer hallmark, yet the dynamics of DNA methylation changes in human carcinogenesis remain largely unexplored. Moreover, the role of DNA methylation for prediction of clinical outcome is still uncertain and confined to specific cancers. Here we perform the most comprehensive study of DNA methylation changes throughout human carcinogenesis, analysing 27,578 CpGs in each of 1,475 samples, ranging from normal cells in advance of non-invasive neoplastic transformation to non-invasive and invasive cancers and metastatic tissue.

Sexual behavior and HPV infection in British women, by postal questionnaires and telephone interviews.

Sexually transmitted human papillomaviruses (HPVs), most frequently HPV 16, are the primary cause of cervical carcinogenesis. The aim of this study was to evaluate the relationship between sexual behavior and prevalence and acquisition of HPV infection among British women attending regular cervical screening who responded to postal questionnaires and/or telephone interviews. A total of 1,880 women who had been tested for HPV in the ARTISTIC (A Randomized Trial In Screening To Improve Cytology) trial were randomized to three methods of data collection: group 1 (questionnaire including sexual history, no interview), group 2 (questionnaire excluding sexual history, short interview including sexual history), and group 3 (questionnaire and long interview including sexual history in both).

A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: extended follow up in the ARTISTIC trial.

Background: The additional sensitivity of HPV testing compared with cytology could permit extended cervical screening intervals. We wished to determine, through a further (third) round of screening in the ARTISTIC trial, the protection provided by a negative baseline HPV screen compared with that of cytology over a 6 year period.

Methods: Cumulative rates of CIN2 or worse (CIN2+) and CIN3 or worse (CIN3+) were correlated with baseline HPV status and cytology.

HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial.

Background: Testing for human papillomavirus (HPV) DNA is reportedly more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN). The effectiveness of HPV testing in primary cervical screening was assessed in the ARTISTIC trial, which was done over two screening rounds approximately 3 years apart (2001-03 and 2004-07) by comparing liquid-based cytology (LBC) combined with HPV testing against LBC alone.

Methods: Women aged 20-64 years who were undergoing routine screening as part of the English National Health Service Cervical Screening Programme in Greater Manchester were randomly assigned (between July, 2001, and September, 2003) in a ratio of 3:1 to either combined LBC and HPV testing in which the results were revealed and acted on, or to combined LBC and HPV testing where the HPV result was concealed from the patient and investigator.

Potential applications of oral brush cytology with liquid-based technology: results from a cohort of normal oral mucosa.

Fifty healthy volunteers were studied to assess the potential applications of oral brush sampling using liquid-based cytology. Three specimens from the buccal mucosa and lateral border of tongue were collected from each subject by using cervical brushes and brooms. The brush was immersed in a preservative fluid.