Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Cervical cancer is a type of cancer that develops in a woman's cervix (the entrance to the womb from the vagina). It is the second most common cancer in women, and develops as a rare consequence of Human PapillomaVirus (HPV) infection. Cervical screening involves collecting cells from the surface of the cervix in order to detect and remove any abnormal cells. The aim of this study is to evaluate the effectiveness of alternative screening techniques for cervical cancer (screening that uses an automated method to analyse the cells, and screening that tests for HPV DNA) compared with conventional screening.

Who can participate?
Women invited to the routine cervical cancer screening programme

What does the study involve?
Participants are randomly allocated to undergo automation-assisted screening, HPV-DNA based screening, or conventional screening.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Finnish Cancer Registry (Finland)

When is the study starting and how long is it expected to run for?
January 1999 to December 2020

Who is funding the study?
Finnish Cancer Registry (Finland)

Who is the main contact?
Dr Ahti Anttila

Trial website

Contact information



Primary contact

Dr Ahti Anttila


Contact details

Liisankatu 21 B
+358 50 3809514

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Alternative technologies in cervical cancer screening


Study hypothesis

Cervical cancer, the second most common cancer in women worldwide, develops as a rare consequent of common Human PapillomaVirus (HPV) infection. Precancerous lesions precede development of invasive cancer.

To evaluate effectiveness of alternative screening techniques using register-based cervical cancer incidence and mortality as the gold standard. Along with sensitivity, also specificity and corresponding test and treatment rates will be compared between the screening modalities.

Ethics approval

There is a continuous linkage between invitation, screening and cancer registry files, based on the national legal framework for organised screening (Act and By-law on Public Health, 1992) and for data collection within health care in Finland (Act and By-law on National Personal Records Kept under the Health Care System, 1989). Study protocols and information procedures for each individual technique currently under evaluation have been accepted by Ethical Committee of the National Research and Development Centre for Welfare and Health (STAKES, 4151/54/98), by the Ethical Committee of the Obstetrics and Gynaecology in Hospital District of Helsinki and Uusimaa (221/E8/02), by the National Authority for Medicolegal Affairs (3950/32/300/02).

Study design

Prospective randomised evaluation trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Cervical cancer


Alternative screening techniques (automation-assisted cytological screening, and HPV-DeoxyriboNucleic Acid [DNA] based screening) are compared to conventional cytological screening.

Intervention type



Not Specified

Drug names

Primary outcome measure

Subsequent cervical cancer incidence among women invited

Secondary outcome measures

1. Mortality from cervical cancers.
2. Detection and incidence of precancerous lesions

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Women invited to routine cervical cancer screening programme within municipalities contracted

Participant type


Age group

Not Specified



Target number of participants


Participant exclusion criteria


Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Liisankatu 21 B

Sponsor information


Finnish Cancer Registry (Finland)

Sponsor details

Liisankatu 21 B

Sponsor type

Research organisation



Funder type


Funder name

Finnish Cancer Registry (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

European Commission (Belgium) - Europe Against Cancer action programme, through European Cervical Cancer Screening Network (ref: SPC.2002475)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Finnish Cancer Organisations (Finland) (grant refs: 14.11.2003, 11.11.2004)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Academy of Finland (Finland) (ref: 73399, date: 25.10.2000)

Alternative name(s)

The Academy of Finland, Suomen Akatemia, Finlands Akademi

Funding Body Type

government organisation

Funding Body Subtype

National government



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2003 results in
2. 2004 results in
3. 2005 interim evaluation of the automation-assisted screening in
4. 2005 results on the cross-sectional relative validity parameters for routine hrHPV screening in
5. 2006 protocol in:
6. 2006 results in
7. 2009 results in
8. 2010 results in
9. 2012 results in
10. 2013 results in

Publication citations

  1. Results

    Anttila A, Kotaniemi-Talonen L, Leinonen M, Hakama M, Laurila P, Tarkkanen J, Malila N, Nieminen P, Rate of cervical cancer, severe intraepithelial neoplasia, and adenocarcinoma in situ in primary HPV DNA screening with cytology triage: randomised study within organised screening programme., BMJ, 2010, 340, c1804.

  2. Results

    Leinonen MK, Nieminen P, Lönnberg S, Malila N, Hakama M, Pokhrel A, Laurila P, Tarkkanen J, Anttila A, Detection rates of precancerous and cancerous cervical lesions within one screening round of primary human papillomavirus DNA testing: prospective randomised trial in Finland., BMJ, 2012, 345, e7789.

  3. Results

    Malila N, Leinonen M, Kotaniemi-Talonen L, Laurila P, Tarkkanen J, Hakama M, The HPV test has similar sensitivity but more overdiagnosis than the Pap test--a randomised health services study on cervical cancer screening in Finland., Int. J. Cancer, 2013, 132, 9, 2141-2147, doi: 10.1002/ijc.27850.

  4. Nieminen P, Hakama M, Viikki M, Tarkkanen J, Anttila A, Prospective and randomised public-health trial on neural network-assisted screening for cervical cancer in Finland: results of the first year., Int. J. Cancer, 2003, 103, 3, 422-426, doi: 10.1002/ijc.10839.

  5. Nieminen P, Vuorma S, Viikki M, Hakama M, Anttila A, Comparison of HPV test versus conventional and automation-assisted Pap screening as potential screening tools for preventing cervical cancer., BJOG, 2004, 111, 8, 842-848, doi: 10.1111/j.1471-0528.2004.00210.x.

  6. Nieminen P, Kotaniemi L, Hakama M, Tarkkanen J, Martikainen J, Toivonen T, Ikkala J, Luostarinen T, Anttila A, A randomised public-health trial on automation-assisted screening for cervical cancer in Finland: performance with 470,000 invitations., Int. J. Cancer, 2005, 115, 2, 307-311, doi: 10.1002/ijc.20902.

  7. Kotaniemi-Talonen L, Nieminen P, Anttila A, Hakama M, Routine cervical screening with primary HPV testing and cytology triage protocol in a randomised setting., Br. J. Cancer, 2005, 93, 8, 862-867, doi: 10.1038/sj.bjc.6602799.

  8. Davies P, Arbyn M, Dillner J, Kitchener HC, Meijer CJ, Ronco G, Hakama M, A report on the current status of European research on the use of human papillomavirus testing for primary cervical cancer screening., Int. J. Cancer, 2006, 118, 4, 791-796, doi: 10.1002/ijc.21611.

  9. Leinonen M, Nieminen P, Kotaniemi-Talonen L, Malila N, Tarkkanen J, Laurila P, Anttila A, Age-specific evaluation of primary human papillomavirus screening vs conventional cytology in a randomized setting., J. Natl. Cancer Inst., 2009, 101, 23, 1612-1623, doi: 10.1093/jnci/djp367.

  10. Protocol

    Anttila A1, Hakama M, Kotaniemi-Talonen L, Nieminen P, Alternative technologies in cervical cancer screening: a randomised evaluation trial, BMC Public Health, 2006, 6, 252, doi: 10.1186/1471-2458-6-252.

Additional files

Editorial Notes

01/04/2016: Plain English summary and publication reference added.