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
ahti.anttila@cancer.fi
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ahti Anttila
ORCID ID
Contact details
Liisankatu 21 B
Helsinki
FI-00170
Finland
+358 50 3809514
ahti.anttila@cancer.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Alternative technologies in cervical cancer screening
Acronym
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.
Hypothesis:
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cervical cancer
Intervention
Alternative screening techniques (automation-assisted cytological screening, and HPV-DeoxyriboNucleic Acid [DNA] based screening) are compared to conventional cytological screening.
Intervention type
Other
Phase
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
01/01/1999
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women invited to routine cervical cancer screening programme within municipalities contracted
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
900,000
Participant exclusion criteria
N/A
Recruitment start date
01/01/1999
Recruitment end date
31/12/2020
Locations
Countries of recruitment
Finland
Trial participating centre
Liisankatu 21 B
Helsinki
FI-00170
Finland
Sponsor information
Organisation
Finnish Cancer Registry (Finland)
Sponsor details
Liisankatu 21 B
Helsinki
FI-00170
Finland
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Finnish Cancer Registry (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Location
Funder name
Finnish Cancer Organisations (Finland) (grant refs: 14.11.2003, 11.11.2004)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Location
Finland
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 http://www.ncbi.nlm.nih.gov/pubmed/12471627
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15270934
3. 2005 interim evaluation of the automation-assisted screening in http://www.ncbi.nlm.nih.gov/pubmed/15688388
4. 2005 results on the cross-sectional relative validity parameters for routine hrHPV screening in http://www.ncbi.nlm.nih.gov/pubmed/16189520
5. 2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17042938
6. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16287075
7. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19903804
8. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20423964
9. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23197596
10. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22987601
Publication citations
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.