”Randomised Studies of Screening for Human Papillomavirus Infection within
Organized Cervical Screening Programs”
A Europe against Cancer project coordinating 3 HPV screening trials in Sweden,
Holland and Finland.
SCIENTIFIC REPORT OF THE FINNISH TRIAL:
A Prospective Pilot Study on HPV-DNA Based Screening for Cervical Cancer
Merja Viikki, Pekka Nieminen, Matti Hakama, Ahti Anttila
Mass Screening Registry, Finnish Cancer Registry, Helsinki, Finland
Tampere School of Public Health, University of Tampere, Tampere, Finland
Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Helsinki,
Finland
Contact person for the EAC/Cervical cancer screening network:
Dr Ahti Anttila, Finnish Cancer Registry, Liisankatu 21 B, FIN-00170 Helsinki
Finland, e-mail: ahti.anttila@cancer.fi
Report of the activity and results for the period 30.8.1999-15.12.2000
Background and aims
Human papillomavirus (HPV) is regarded as the most important risk factor for cervical cancer
and for its precursors. HPV testing has not yet been entered in the routine cytological
screening programme, however. Therefore, there are numerous technical and validation
aspects, such as assessment of sample-taking and processing details, optimising clinical
sensitivity and specificity that need to be solved. In addition, training, comparing the results
with already established HPV laboratories abroad and organisational details, e.g. the demand
of laboratory resources, and the total cost, should be considered before large-scale HPV
testing can be started.
In the Finnish context, hospital smears are especially suitable for the pilot study since their
background rate of histologically confirmed cancerous and precancerous lesions is much
higher than that in routine mass screening; sufficient statistical power in differential detection
can be obtained with a smaller study population.
We have started a prospective primary HPV-DNA screening pilot in September 2000, to
evaluate the clinical and diagnostic aspects of HPV testing in Finland for its use in screening
for cervical cancer.
RESULTS: WORK DONE
During the period up to 15th December 2000, altogether 1450 HPV and liquid-based samples
have been collected. The sample collection and processing has been the following:
One VCE sample (taken with a brush and a wooden spatula) per woman was taken for the
conventional pap-smear and for the liquid-based smear (Cytyc Thinprep) and one additional
brush sample for HPV-detection with Hybrid capture II, Digene. In addition to the manual
reading of the conventional and liquid-based smears also the automation-assisted pap smear
screening device (Papnet) are used the analysis of the smears. HPV-DNA analysis will also be
processed for each of the women. The women with positive cytological results, or with
repeated suspicious results, with any of the methods, or with clear symptoms, will be sent to
colposcopic examination including histological confirmation.
There are five different methods (routine manual, automation-assisted manual, liquid-based
manual, liquid-based automation-assisted, and HPV-DNA detection) to be compared in a
split-sample and prospective designs. The four different cytological screening methods are
processed in Finland. For the HPV-DNA analysis the samples have been shipped to the
Digene's laboratory in the United States for analysis.
Two cytology assistants have been trained for the Thinprep technique.
The overall study size will be 2000 women. The rest of the study material has been collected
during December 16, 2000 - January 2001. No results of the cytological, histological nor
HPV-DNA are available yet.