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Alternative technologies in cervical cancer screening
ISRCTN ISRCTN23885553
DOI 10.1186/ISRCTN23885553
ClinicalTrials.gov identifier
EudraCT number
Public title Alternative technologies in cervical cancer screening
Scientific title
Acronym N/A
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Finland
Disease/condition/study domain Cervical cancer
Participants - inclusion criteria Women invited to routine cervical cancer screening programme within municipalities contracted.
Participants - exclusion criteria N/A
Anticipated start date 01/01/1999
Anticipated end date 31/12/2020
Status of trial Ongoing
Patient information material
Target number of participants 900,000
Interventions Alternative screening techniques (automation-assisted cytological screening, and HPV-DeoxyriboNucleic Acid [DNA] based screening) are compared to conventional cytological screening.
Primary outcome measure(s) Subsequent cervical cancer incidence among women invited.
Secondary outcome measure(s) 1. Mortality from cervical cancers.
2. Detection and incidence of precancerous lesions.
Sources of funding 1. Finnish Cancer Registry (Finland)
2. European Commission (Belgium) - Europe Against Cancer action programme, through European Cervical Cancer Screening Network (ref: SPC.2002475)
3. Finnish Cancer Organisations (Finland) (grant refs: 14.11.2003, 11.11.2004)
4. Academy of Finland (Finland) (ref: 73399, date: 25.10.2000)
Trial website
Publications 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
Contact name Dr  Ahti  Anttila
  Address Liisankatu 21 B
  City/town Helsinki
  Zip/Postcode FI-00170
  Country Finland
  Tel +358 50 3809514
  Fax +358 9 1355378
  Email ahti.anttila@cancer.fi
Sponsor Finnish Cancer Registry (Finland)
  Address Liisankatu 21 B
  City/town Helsinki
  Zip/Postcode FI-00170
  Country Finland
  Sponsor website: http://www.cancerregistry.fi
Date applied 15/08/2006
Last edited 08/05/2013
Date ISRCTN assigned 29/09/2006
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