Self-collected specimens in the fight against cervical cancer

Published 19.01.2018, updated 19.01.2018

Self-collected specimens is a good alternative to gynecological examination

We have shown that home testing is well-accepted among women, and that a self-administered cell sample is just as effective as one taken by a healthcare provider. Only 19% of study participants preferred a healthcare provider-administered test. The test for high-risk human papillomavirus (hrHPV) performed equally well on home-collected cell samples as it did on samples collected by healthcare providers. Based on findings from this study, the Cervical Cancer Screening Program has now introduced home testing as an option for a selected group of women.

The HPV test is highly sensitive in identifying precursors to cervical cancer, but there is a need for more knowledge on how to distinguish between "dangerous" and "harmless" HPV infections. This is because only a small proportion of HPV infections and low-grade precursors progress to life-threatening cervical cancer, while most cases spontaneously regress to a normal state. Therefore, an additional analysis is needed to improve accuracy and prevent over-treatment.

Increased participation

In the first part of the project, the Cancer Registry showed that 44% more women could be screened for cervical cancer when they had the option to take a home-based cell sample instead of visiting a healthcare provider. The increase was most significant among women under 35 years old, with up to 60% more women undergoing cervical cancer screening due to the option of taking a home-based cell sample.

Recently, a collaborative study with the Harvard T. H. Chan, School of Public Health in the USA also demonstrated that such a home-based test is additionally cost-effective. for society.

Recruitment

Recruitment for the study was concluded in September 2016. A total of 310 women who had been diagnosed with cell changes or cervical cancer were encouraged to take a cell sample at home using two different devices (Evalyn® Brush and FLOQSwabs™) the day before their scheduled treatment appointment. At the hospital, another cell sample was taken by a physician. These samples, along with a urine sample, were then sent to the laboratory for analysis using the HPV test.

Comparable to current practice

The study showed that when a home test is used to test for the presence of hrHPV, followed by further follow-up, it captures as many women with severe cell changes or cervical cancer as when a cervical sample is taken by a doctor. Additionally, the hrHPV home test performed better than cytology-based screening.

The equipment and delivery costs are the most important factors affecting whether home testing becomes cost-effective or not. The study examined two different equipment packages intended for home use. If the equipment was analyzed within four weeks, both equipment packages were equally effective as a sample taken by a doctor.

However, if the analysis of the home test was delayed by more than four weeks, differences were found in the home test's ability to identify cell changes requiring treatment.

The project also investigated whether women were satisfied with the testing equipment and the reliability of the home test. Women found that home testing was a good alternative to a sample taken by a doctor. Experiences with home testing were very positive, and most of the women preferred home testing as a screening method in the future, even though they trusted a sample taken by a doctor more.

Increase knowledge of self-collection

The study has contributed to increased knowledge about methods for detecting cell changes and cancer in the cervix. In order to offer an alternative to doctor-collected cervical samples to those who need it, we will continue to investigate how home testing can reduce the need for a gynecological examination.

This knowledge will benefit women in the future, both in Norway and especially in countries that do not have organized cervical cancer screening programs.

The biological material from the women who have given their consent for us to store it in a research biobank can be used in additional cancer-related research studies in the future.

Status

HPV home testing is now being introduced into the Cervical Cancer Screening Program. Several articles have been published, but the work on in-depth analysis of the data is still ongoing. Additionally, we will investigate whether laboratory analyses such as methylation analysis work equally well on samples taken at home and those taken by a doctor. Efforts are underway to write more articles presenting additional results from the study.

Collaboration