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The Predictors 5.2 Study

The Predictors 5.2 is a study comparing self-collected vaginal and urine samples with clinician-taken cervical samples for high-risk HPV testing to support more accessible cervical screening.

The Predictors 5.2 Study
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Predictors 5.2

Full 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

Study acronym: Predictors 5.2

Sponsor: Queen Mary University of London

Chief Investigator: Prof Ranjit Manchanda, Professor of Gynaecological Oncology & Consultant Gynaecological Oncologist, Queen Mary University of London

Contact: r.manchanda@qmul.ac.uk (Ranjit Manchanda)

IRAS ID: 311023

Background:

The PREDICTORS 5.2 study tests whether self-collected vaginal swabs and urine samples are as reliable as clinician-taken cervical samples in detecting high-risk human papillomavirus (HPV). The goal is to assess if self-sampling could broaden screening access, increase uptake, and detect early precancerous changes more effectively — especially in individuals who skip clinic-based screening.

Self-sampling could reduce barriers such as discomfort, embarrassment, scheduling difficulties or clinic access. Alongside HPV testing, molecular assays (like methylation and genotyping) were evaluated to see if self-samples are robust enough for advanced diagnostic workflows.

Purpose of the Study:

Cervical screening helps detect early cell changes caused by high-risk HPV that can lead to cervical cancer. Yet many people avoid screening - currently over 1 in 5 eligible women skip it often due to discomfort or accessibility issues. Predictors 5.2 explores whether self-sampling (vaginal swab or urine) could work as an accurate, convenient alternative to clinic-based sampling. If successful, this could increase participation and reduce the number of cervical cancers by catching more pre-cancer changes earlier.

A further aim was to evaluate lab processes: to test if self-samples maintain DNA integrity and are suitable for sensitive HPV detection and advanced assays, like methylation or genotyping, to help stratify risk more accurately.

Recruitment Status:

- Status: Complete - samples collected, follow-up and lab analysis concluded

- First participant enrolled: 29/04/2024

- Date of final enrolment: 21/10/2024

- Total participants enrolled: 175

Study Objectives:

The study aims to assess how suitable different self-sampling methods are for HPV testing, particularly by comparing samples transported dry and wet. The first phase focused on determining the quality of DNA obtained from various self-collection and storage approaches for both vaginal and urine samples, helping to establish optimal sampling protocols for future use. Alongside evaluating DNA integrity and storage effects, researchers compared self-collected samples directly with clinician-taken cervical samples to understand their relative performance in subsequent molecular tests.

Eligibility:

Participants were eligible if they:

  • Were 25–65 years old

  • Were scheduled for examination at colposcopy (due to abnormal screening cytology and/or positive HPV result) at the Royal London Hospital

  • Were willing and able to give written consent

 

What Did Participation Involve?

Each participant provided:

  1. A clinician-taken cervical sample (standard of care)

  2. A self-collected vaginal swab (two types of swabs used in pre-specified order)

  3. A self-collected urine sample on the same day

  4. Optionally, a second urine sample at home (ideally the next day), returned to the lab by post

Samples were either tested immediately, or stored (wet or dry) for up to two weeks to assess DNA stability and test performance under real-world conditions.

Participants also completed a short questionnaire about ease and acceptability of self-sampling.

Study Design & Status:

PREDICTORS 5.2 is a diagnostic/comparative observational study. It compares matched samples collected via different methods (self-collected vs clinician-collected) from the same individuals. All sampling and recruitment is now complete, and laboratory testing has concluded. Results have been analysed and summarised.

Study Results:

The study found that self-collected vaginal swab samples—whether stored dry or wet—produced DNA quality comparable to clinician-collected cervical samples, even when processing was delayed for up to two weeks. Urine samples, however, were slightly less effective for detecting HPV compared with both vaginal and cervical swabs. Overall, the results support vaginal self-sampling, particularly when paired with appropriate storage methods, as a reliable alternative for HPV-based cervical screening. This approach has the potential to increase screening participation and enhance early detection of cervical abnormalities.

Significance:

PREDICTORS 5.2 contributes important evidence towards more accessible, patient-friendly cervical screening. By showing self-sampling viability, the study supports efforts to reduce barriers to screening and increase uptake — especially among under-screened populations. Reliable self-sampling could significantly increase the reach and effectiveness of early detection programmes.

As national screening policies evolve, such evidence can inform decisions on offering self-sampling as a standard option, improving public health outcomes.

Study Completion Date:

  • 05/11/2024 - Completed

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