Predictors 5.2
Research type
Research Study
Full title
Comparison of high risk HPV positivity of a vaginal self sample and urine sample with a clinician taken cervical sample taken at the same screening visit.
IRAS ID
311023
Contact name
Ranjit Manchanda
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Summary of Research
Women who test positive for high risk HPV may be at risk of developing cervical cancer. High risk HPV is associated with cervical cancer but most women clear the infection themselves and not develop cancer. We can test for HPV and in the future HPV testing is likely to replace cytology as the primary cervical screening test. It has the potential for self sampling as a woman can use a simple swab or a commercially designed swab kit to take a 'self sample' for HPV. The study aims to look at the non inferiority between the use of self sampling equipment compared to the standard clinician taken test. We aim to recruit 2000 women over a period of 12 months. Women will be approached at their GP clinic on the day of their regular cervical screening test. The GP admin team will send out information relating to the study prior to them attending so that they are aware that they may be approached on the day of their appointment about whether they wish to participate in the study.
Before their cervical screening test, women will be asked to sign a consent form confirming that they are happy to take part in the study, will be asked to provide a urine sample and take two self samples using vaginal swabs:
1) Digene Dacron Swab
2) Copans Floq Swab (like cotton bud).The women will be given an illustrated instruction sheet within the self test kits and the kits will contain both types of swabs and the urine collection device. The study team will make up the packs and two swabs will be taken in a pre specified order. This will all be documented within the instruction sheet. They will also be asked to fill out a short questionnaire about ease and acceptability.
Summary of Results
Study title
Comparison of high-risk HPV positivity of a vaginal self-sample and urine sample with a clinician taken cervical sample at the same screening visit.Who carried out the research? (including details of sponsor, funding and any competing interests)
The study was conducted by the Barts Clinical Trials Unit, Centre for Evaluation & Methods and Molecular Epidemiology Lab, Centre For Cancer Screening, Prevention and Early Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London.The study was sponsored by Queen Mary University of London and funded by Cancer Research UK.
No competing interests have been declared.
What public involvement there was in the study (how many people, what their relevant lived experience was, and what they did)
Cervical Cancer Trust provided review and feedback of study design and study documents such as patient information sheets and consent forms. Overall positive feedback was received with minor adjustments made to patient facing documents.Where and when the study took place
The study involved 175 participants attending Royal London colposcopy clinic between 29th April 2024 to 21st October 2024.Why was the research needed?
Cervical screening (a test to detect abnormal cells in the cervix by checking for the presence of high-risk types of the Human Papillomavirus (HPV) which can cause abnormal cell changes) is crucial for detecting early signs of cervical cancer, often using samples collected by healthcare professionals. However, self-collected vaginal and urine samples could offer a more convenient and an accessible alternative.
Currently more than 1 in 5 eligible women invited for cervical screening do not attend, and their risk of cervical cancer increases consequently. Offering an alternative option to the current screening method, which requires attendance at a clinic and a test which can be difficult and uncomfortable for many women, may increase compliance and improve timeliness of having their screening test performed. Therefore, it is anticipated that a screening strategy including self-sampling will reduce the number of women being diagnosed with cervical cancer by identifying more disease at the pre-cancerous stage.
Self-sampling has been found to be widely acceptable to women and is likely to increase screening uptake and coverage and has the potential to become the routine test for the majority of women. It also has the potential to greatly reduce the cost of screening by only requiring the 5-15% of women with a positive self-test result, depending on age, to need to see a doctor.
Further efficiencies in self-sampling may be achievable by using methylation, genotyping and other assays on the self-sample.
These tests help to better identify which HPV infections are most likely to be linked with changes in the cervix that could develop into cancer. Methylation testing, in particular, looks for specific changes in the DNA of cells that are more often seen when a high-risk HPV infection is already causing early signs of disease. This means that women who test positive for HPV can be more accurately sorted and some can safely avoid further tests, while others can be referred more quickly for treatment if needed. By using these additional tests, the screening process can become not only more accurate, but also more efficient and less stressful for women, especially when combined with a more comfortable, home-based testing option.
This study will evaluate the suitability of laboratory processes to test self-samples using different methods. The purpose of this study is therefore to help define laboratory processes to ensure suitability of the self-sample for HPV testing.What were the main questions studied?
To evaluate the suitability of different self-sampling methods for Human Papillomavirus (HPV) testing, particularly comparing samples transported dry versus wet.
The primary aim of the first phase of this study was to evaluate the quality of DNA obtained from various self-collection and storage methods for both vaginal and urine samples, to establish optimal sample collection protocols for future studies.
In addition to assessing sample integrity, self-collected samples were compared directly with clinician-taken cervical samples to evaluate their relative suitability for downstream molecular analyses.Who participated in the study?
Women were eligible for the study if aged between 25-65 years and attending examination at the Royal London Hospital colposcopy clinic as a consequence of an abnormal screening cytology and/or positive HPV result. Participants were also required to be willing and able to give written informed consent.What treatments or interventions did the participants take/receive?
Following informed consent, participants provided self-collected vaginal and urine samples, alongside clinician-collected cervical samples. Participants were also asked to provide an optional second urine sample at home, ideally on the following day and return it to the lab within a week by post.Samples were tested immediately or stored for up to two weeks to assess the impact of storage conditions on DNA quality.
What medical problems (adverse reactions) did the participants have?
No safety issues were anticipated in this low-risk study and the use of urine and swabs for self-sampling is relatively common practice.
No participants experienced any adverse events during the study.What happened during the study?
Eligible participants attending the colposcopy clinic were approached about the study and provided with a Patient Information Sheet (PIS) which was discussed with the participant, and participants were given the opportunity to ask questions. Participants then signed the study Consent Form if they agreed to participate. Those that did not consent to participate were informed that they would continue to receive usual care.
Participants were provided with a pre-labelled sample kit and shown to a lavatory within the clinic and asked to provide a urine sample and two self-collected vaginal samples (one wet and one dry sample). Written and diagrammatic instructions were provided within the sampling kit. The participant would then carry on with their routine colposcopy appointment where a clinician cervical sample will be taken. The sample pack also include an additional urine collection device for collection at home as previously described.What were the results of the study?
Results showed that dry self-collected vaginal samples had DNA quality comparable to wet samples and clinician-collected samples, even when processed up to two weeks after arrival at the lab. However, urine samples were slightly less effective for HPV detection. Additionally, the S5 methylation assay (a specialised DNA test) showed inconsistencies in detecting HPV-related changes across all sample types.How has this study helped patients and researchers?
Overall, the findings suggest that self-collected vaginal samples ”whether stored wet or dry up to 2 weeks” are a viable option for HPV testing. This could expand access to cervical screening, making it easier for individuals to participate in early detection efforts.
• Details of any further research planned
Samples will be stored in MEL biobank and might be used for future research to improve cervical cancer or gynaecological cancers detection.Where can I learn more about this study?
Further information regarding the study can be found on the ISCRTN registry. (ISRCTN78093478)REC name
London - Central Research Ethics Committee
REC reference
22/PR/1146
Date of REC Opinion
9 Nov 2022
REC opinion
Further Information Favourable Opinion