Projects

• Enhancing the Evidence Base for Cost-Effectiveness Analysis in Ireland: Building Improvements from the Intervention-Specific to System-Wide Levels
  Dr James O’Mahony is leading this Health Research Board Emerging Investigator Award (EIA) which contains three principal components. The first addresses the theoretical and empirical basis for the cost-effectiveness threshold used to determine if an intervention represents good value for money. The second examines common methodological problems in cost-effectiveness analyses of cancer screening and proposes a simple simulation modelling framework for use as a teaching and method research tool to help avoid such problems. The final component uses microsimulation modelling to simulate the cost-effectiveness of novel triage techniques for women tested as positive for the human papillomavirus (HPV) at primary screening and to investigate the potential of HPV self-sampling for the prevention of cervical cancer in women who do not typically participate in cervical screening. Dr O’Mahony is accompanied on the EIA programme by doctoral candidate Ms Yi-Shu Lin. James and Yi-Shu work conjunction with the CERVIVA multi-disciplinary research consortium, which investigates the diagnosis and prevention of HPV-associated cancers. Other research partners on the programme include participants based at the Royal College of Surgeons in Ireland and the Erasmus Medical Centre, Rotterdam.
  Last updated 2019
• CERVIVA-Vax: Monitoring the impact of HPV vaccination in Ireland
  Infection with Human Papillomavirus (HPV) can lead to development of cervical cancer. For this reason HPV now plays an important role in cervical cancer prevention. For example, HPV vaccination programmes are established in several countries worldwide, including Ireland, where a national school based HPV vaccination programme began in 2010.
  
  The vaccine does not protect against all HPV as it only targets the main HPV types. So it is important that all women, aged 25- 60, continue to have regular cervical smear tests through the CervicalCheck programme. Very soon the first set of women who have received the vaccine through the school programme, will be eligible to attend for their first CervicalCheck smear. It is important that we monitor the impact of vaccination in those that have received the vaccine to identify if it reduces the prevalence of HPV and cytological abnormalities. It is also important that we look at how the current tests we use for cervical screening in unvaccinated women perform in women who have received the vaccine. Furthermore, it is vital to understand if whether a woman is vaccinated (or not) affects whether she attends for screening.
  
  In CERVIVA-Vax, we will (1) investigate the number and type of HPV infections detected in women who have received the HPV vaccine and attend cervical screening; (2) explore how current screening tests perform in women who are vaccinated; (3) observe screening uptake in vaccinated women compared to unvaccinated women.
  
  Changes in screening uptake, HPV infections and detection of cervical abnormalities may have an adverse effect on how well screening works for individual women and the population. By investigating the early impact of HPV vaccination on screening in Ireland, CERVIVA-Vax will be able to inform CervicalCheck, and international screening programmes, of the best cervical screening approach for both vaccinated and unvaccinated women.
  Last updated 2019
• What influences cervical screening uptake in older women and how can screening programmes translate this knowledge into behaviour changing strategies? A qualitative and quantitative research project
  
  Achieving high cervical screening coverage is important both for the population and individual women. However older women in Ireland are less likely to engage with cervical screening. The aims of the project are (i) to understand non-participation in cervical cancer screening among older women and (ii) to explore women’s present level of understanding of cervical screening in Ireland.
  This project is co-funded by the Health Research Board, Applied Partnership Award Scheme and by the National Screening Services.
  Project partners: Trinity College Dublin (lead), CervicalCheck, The National Screening Services (co-lead), The National Cancer Registry and Newcastle University.
  Last updated 2019
• HPV Primary Screening Pilot Study: molecular testing of potential triage strategies for HPV-positive women
  Each year, about 295 women in Ireland are diagnosed with cervical cancer. Smear tests/cervical screening is an effective way to reduce your risk of getting cervical cancer. CervicalCheck the national cervical cancer screening programme offers free smear tests to women aged 25 – 65 years. However, some women, particularly women over 50, do not attend for these important tests. We want to find out what women aged 50 – 65 years in Ireland think about cervical screening and smear tests.
  The presence of HPV does not always lead to the development of cervical cancer. To ensure HPV testing is effective, we need to find out which HPV positive samples are likely to develop into cancer. To do this, we will look into samples that test positive for HPV in a little more detail. We will do additional tests to look for specific markers that we know are linked to HPV infection. The additional tests will include cytology, HPV 16/18/45 genotyping, p16INK4a/ki67, methylation markers and RAMAN Spectroscopy. By following women to see what happens over the course of several smear tests, over 10 years, we will be able to determine how useful these new approaches to cervical screening are.
  Last updated 2019
• HPV and biomarker screening
  HPV infections play a crucial role in the aetiology of cervical lesions. Various molecular assays have been developed to detect HPV. HPV DNA testing is already being used for the management of cervical disease. While it is generally accepted that HPV DNA testing is more sensitive for detection of cervical disease compared with cytology, it is less specific in particular in younger age groups, largely due to the high prevalence of transient HPV infections. As a consequence, the appropriate framework for HPV testing is paramount to avoid unnecessary testing and follow up. There is a clear need to improve the specificity of HPV DNA testing, and this can be achieved at various levels, including HPV genotyping and viral load assessment. An alternative approach is to triage with some form of secondary biomarkers. Several biomarker options exists for this including (1) measuring HPV E6 and E7 mRNA transcripts, (2) alterations to methylation patterns of several genes, (3) alterations of viral and host genomes (4) detection of cellular proteins overexpressed in HPV infected cells.
  
  Within this project, CERVIVA aims to address the need for additional triage markers for cervical screening through evaluation of a combined approach of HPV DNA, HPV mRNA, p16INK4A/ki67 and a novel panel of 20 mRNA biomarkers developed as part of an FP7 funded programme grant "AutoCast" in a colposcopy controlled study. The data generated from this colposcopy controlled study will support a primary screening algorithm of primary HPV testing followed by biomarker triage.
  This will be the first study to evaluate all three biomarker sets in a single population.
  Last updated 2015
• Raman spectroscopy in the diagnosis of cervical cancer
  This project aims to develop a novel tool for cervical cancer screening based on low resolution Raman spectroscopy.
  Raman spectroscopy is a powerful tool that can generate a biochemical fingerprint of a sample in a rapid and non-destructive manner. A large library of Raman spectra from a wide sample base including all grades of cervical intraepithelial neoplasia (CIN I, II and III) is being recorded and used to develop an algorithm which can classify unknown spectra based on biochemical changes corresponding to disease onset. The Raman system was developed in progenitor projects, and could discriminate normal and abnormal cervical cytology samples based on the biochemical fingerprint of the cells with high sensitivity and specificity.
  Dr. Lyng, together with her colleagues at the Radiation and Environmental Science Centre at the Focas Institute in DIT and collaborators at the Coombe Women and Infants University Hospital aim to develop a second generation Raman system, Cervassist, capable of detecting both HPV infection and cellular abnormalities related to cervical intraepithelial neoplasia in exfoliated cervical cells on the same Thinprep slide.
  Enterprise Ireland, who have funded the development of this technology for five years, awarded Dr. Fiona Lyng of Dublin Institute of Technology their 2011 “One to Watch” award for her role in the development of this innovation.
  Last updated 2015
• AUTOCAST: The future of cervical cancer screening
  Cancer accounts for nearly one-quarter of deaths in the developed world, exceeded only by heart diseases. Early diagnosis through cancer screening programs is one of the key methods facilitated in cancer prevention as it has the: Capability of reducing mortality; and Potential to reduce cancer severity due to treatment for earlier stage cancers often being less aggressive than that for advanced-stage disease.
  Whilst cancer screening provides the possibility for earlier detection and treatment, such screening programs currently present issues concerning inaccurate results, extensive delays in acquiring results, and holdups in starting treatment. For this reason, it is important that new technologies and approaches are developed. The AUTOCAST project took cervical cancer (the second most common cancer in women worldwide) and its associated virus Human Papilloma Virus (HPV) as the model system to develop a novel, automated cancer screening technology which could improve the way that patients are screened.
  AUTOCAST has provided a low-cost novel solution for cervical screening, by developing a unique, automated polymerase chain reaction (PCR) technology able to detect multiple HPV genotypes and cervical cancer biomarkers in parallel within a single smear test. Based on a microfluidic disposable cartridge which is capable of real-time PCR amplification and detection in microarray format, this can then be processed to allow for a rapid ‘point-of-care’ diagnostic.
  The concept of a ‘point-of-care’ cervical cancer screening will help to improve cervical pre-cancer and cancer detection as it means that ultimately, a doctor will be able to take a smear sample from a woman and immediately test for the presence of HPV and biomarkers to determine whether that woman is at risk of developing cervical cancer. Such technology will provide information about the presence of the HPV, their genotypes and also about the prognostic, pathological markers such as the viral load and the expression of the biomarkers. In addition, it can reliably distinguish between high and low-grade cervical pre-cancer, a factor that is hugely important for the management of women with abnormal smears. This is an enormous improvement from previous practices where, after sampling, specimens were sent to a central laboratory for pap-smear testing (a manual, microscope-based evaluation).
  Last updated 2015
• MicroActive automatic detection of disease related molecular cell activity
  Many common diseases currently require that samples be sent to remote labs for diagnosis. This is costly and takes time, increasing patient anxiety and delaying the start of treatment. MicroActive will make it feasible to carry out automatic, accurate diagnosis at the local doctor's office.
  MicroActive will develop an integrated system based on microtechnology and biotechnology for automated diagnosis of a wide range of diseases. The system will analyze biological samples and be specifically designed for use in primary health care.
  Microactive will achieve this by using bio-marker mRNA detection. Compared to commonly used approaches (e.g. PCR amplification and immunoassay methods), mRNA detection avoids false positive results and has a high sensitivity. It can currently be used to detect pre-cancer, cancer, STD and a range of respiratory diseases, to mention a few. New bio-markers are being developed every day.
  Last updated 2015

Scientific paper(s)

1. Exploring women's sensory experiences of undergoing colposcopy and related procedures: implications for preparatory sensory information provision
2. Triage of LSIL/ASC-US with p16/Ki-67 dual staining and human papillomavirus testing: a 2-year prospective study
3. Trends in, and predictors of, anxiety and specific worries following colposcopy: a 12-month longitudinal study
4. Understanding Women's Differing Experiences of Distress after Colposcopy: A Qualitative Interview Study
5. Adverse psychological outcomes following colposcopy and related procedures: a systematic review
6. Influences on human papillomavirus (HPV)-related information needs among women having HPV tests for follow-up of abnormal cervical cytology
7. Multicohort Models in Cost-Effectiveness Analysis Why Aggregating Estimates over Multiple Cohorts Can Hide Useful Information
8. Motivators for women to attend cervical screening: the influential role of GPs
9. CERVIVA: The Irish Cervical screening research consortium
10. 'I don't care whether it's HPV or ABC, I just want to know if I have cancer' Factors influencing women's emotional responses to undergoing human papillomavirus testing in routine management in cervical screening: a qualitative study

Presentation(s)

1. An Evaluation of the Role of Triage Markers for Management of HPV Positive Women Presenting at Colposcopy with Minor Cytological Abnormalities
2. Women's differing experiences of distress following colposcopy and related procedures: a qualitative interview study
3. Predictors of anxiety and specific worries after colposcopy within cervical cancer screening: A 12- month longitudinal study
4. Trends in, and predictors of, anxiety and specific worries following colposcopy: a 12 month longitudinal study