Alternative technologies in cervical cancer screening

ISRCTN ISRCTN23885553
DOI https://doi.org/10.1186/ISRCTN23885553
Secondary identifying numbers N/A
Submission date
15/08/2006
Registration date
29/09/2006
Last edited
01/04/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Ahti Anttila
Scientific

Liisankatu 21 B
Helsinki
FI-00170
Finland

Phone +358 50 3809514
Email ahti.anttila@cancer.fi

Study information

Study designProspective randomised evaluation trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAlternative technologies in cervical cancer screening
Study objectivesCervical 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(s)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).
Health condition(s) or problem(s) studiedCervical cancer
InterventionAlternative screening techniques (automation-assisted cytological screening, and HPV-DeoxyriboNucleic Acid [DNA] based screening) are compared to conventional cytological screening.
Intervention typeOther
Primary outcome measureSubsequent cervical cancer incidence among women invited
Secondary outcome measures1. Mortality from cervical cancers.
2. Detection and incidence of precancerous lesions
Overall study start date01/01/1999
Completion date31/12/2020

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants900,000
Key inclusion criteriaWomen invited to routine cervical cancer screening programme within municipalities contracted
Key exclusion criteriaN/A
Date of first enrolment01/01/1999
Date of final enrolment31/12/2020

Locations

Countries of recruitment

  • Finland

Study participating centre

Liisankatu 21 B
Helsinki
FI-00170
Finland

Sponsor information

Finnish Cancer Registry (Finland)
Research organisation

Liisankatu 21 B
Helsinki
FI-00170
Finland

Website http://www.cancerregistry.fi
ROR logo "ROR" https://ror.org/00j15sg62

Funders

Funder type

Government

Finnish Cancer Registry (Finland)

No information available

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

No information available

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

No information available

Academy of Finland (Finland) (ref: 73399, date: 25.10.2000)
Government organisation / Universities (academic only)
Alternative name(s)
Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
Location
Finland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 20/01/2003 Yes No
Results article results 01/08/2004 Yes No
Other publications interim evaluation of the automation-assisted screening 10/06/2005 Yes No
Results article results on the cross-sectional relative validity parameters for routine hrHPV screening 17/10/2005 Yes No
Results article results 15/02/2006 Yes No
Protocol article protocol 16/10/2006 Yes No
Results article results 02/12/2009 Yes No
Results article results 27/04/2010 Yes No
Results article results 29/11/2012 Yes No
Results article results 01/05/2013 Yes No

Editorial Notes

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