Published 19.01.2018, updated 19.01.2018
Can a self-collected specimen be an alternative to a gynecological assessment?
In the cervical cancer screening programme today, a doctor or gynecologist takes a cervical smear during a gynecological assessment. Afterwards, the sample is visually examined under a microscope.
In recent years, more sensitive method to analyse cervical specimens has been developed. Such method is called high-risk human papillomavirus (hrHPV) testing.
This project aims to assess if a specimen taken by a woman herself could replace a gynecologic examination. A self-collected specimen is mailed to a doctor or a laboratory, and only women who test positive for hrHPV will have to see their doctor or gynecologist for further follow-up and gynecologic examination.
In the first part of this project, the Cancer Registry of Norway was able to show that 44% more women could be screened for cervical cancer if they had the option of self-collection in the privacy of their own home, instead of going to the doctor. The increase was highest among women under 35 years of age. In this age group, almost 60% more women were screened because they had the option of taking a specimen in their own home.
A recent collaboration with Harvard T. H. Chan, School of Public Health in USA, found that in addition to recruiting more women to attend cervical cancer screening, screening based on self-collected specimens was also more cost-effective.
In the second part of the project, the Cancer Registry of Norway aims to assess if home-collected specimens are suitable for hrHPV testing, and whether self-collection devices provide specimens with similar quality of sample than cervical specimens taken by doctors have.
Recruitment period ended in September 2016. Altogether 310 women who have had cervical premalignant lesions or cervical cancer have been enrolled to perform self-collection at home using two sampling devices (Evalyn®Brush and FLOQSwabs™) the day before their appointment at the hospital. A doctor took an additional cervical specimen at the hospital. These specimens along with a urine specimen were sent to a laboratory for hrHPV testing.
Comparable to current practice
Study found that hrHPV testing of self-collected specimens was comparable or even better to current screening practice for detecting cervical lesions which require treatment.
The cost of the device and postal costs are the main determinants if self-collection will be a cost-effective method of screening. This study showed that both collection devices were comparable to a physician-collected specimen when preprocessed for hrHPV testing within four weeks. However, delays in shipment and analysis had notable effect on the performance, and this effect varied by collection device.
We also studied women's experiences on self-collection and attitudes towards screening. Study participants considered self-collection to be a good alternative for visiting a doctor. Experiences on self-collection with both devices were very positive. The great majority preferred self-collection as a future's screening method, even though they had more confidence in doctors.
Increase knowledge of self-collection
This study will increase knowledge of new methods that can be useful in cervical cancer prevention. We will continue further to evaluate means to reduce the need for a gynecological assessment with self-collection.
This knowledge will benefit women in the future, not only in Norway, but also in countries without organised screening programmes.
The biological material collected from the consenting women will form part of a research biobank which can later be utilised in other HPV- and cancer-related research projects.
This project is a collaboration coordinated by the Cancer Registry of Norway, and involves two secondary and one tertiary care centers.
Hospitals are responsible for the recruitment, and receiving the tests. The patients with premalignant lesions are recruited from the Østfold Hospital Trust (Sykehuset Østfold) and Oslo University Hospital, Ullevål. Patients with cervical cancer are recruited at the Norwegian Radium Hospital.
If you have any questions regarding your treatment, please contact your hospital. If you have questions regarding this study, please contact the Cancer Registry of Norway.
Leinonen MK, Schee K, Jonassen CM, Lie AK, Nystrand CF, Rangberg A, Furre IE, Johansson MJ, Tropé A, Sjøborg KD, Castle PE, Nygård M.
Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions
J Clin Virol (2017)
Cancer Registry in Norway
Mari Nygård, Giske Ursin, Kristina Schee, Ameli Trompé, Espen Enerly, Madleen Orumaa og Maarit Leinonen.
Radium hospital: Gunnar B. Kristensen og Ingegerd Eggen Furre
Østfold Hospital: Katrine D. Sjøborg, Kathrine Lie, Christine Jonassen, Camilla Furlund Nystrand, Anbjørg Rangberg, Marzena J. Johansson, Torunn Søland og Aud Jaaval
Oslo University Hospital: Thomas Thaulow og Marianne Olsen
Hvidovre Hospital, Denmark: Jesper Bonde
The project is finansed by the Norwegian Cancer Society and the Cancer Registry of Norway.