Plain English Summary

Not provided at time of registration

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

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

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 measures

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

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

http://www.cancerregistry.fi

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)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

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

Results - basic reporting

Publication summary

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 results in http://www.ncbi.nlm.nih.gov/pubmed/16287075
6. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19903804
7. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20423964
8. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23197596
9. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22987601

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.

Editorial Notes