Alternative technologies in cervical cancer screening
| ISRCTN | ISRCTN23885553 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23885553 |
| Protocol serial number | N/A |
| Sponsor | Finnish Cancer Registry (Finland) |
| Funders | Finnish Cancer Registry (Finland), European Commission (Belgium) - Europe Against Cancer action programme, through European Cervical Cancer Screening Network (ref: SPC.2002475), Finnish Cancer Organisations (Finland) (grant refs: 14.11.2003, 11.11.2004), Academy of Finland (Finland) (ref: 73399, date: 25.10.2000) |
- 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
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
Scientific
Liisankatu 21 B
Helsinki
FI-00170
Finland
| Phone | +358 50 3809514 |
|---|---|
| ahti.anttila@cancer.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised evaluation trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Alternative technologies in cervical cancer screening |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Subsequent cervical cancer incidence among women invited |
| Key secondary outcome measure(s) |
1. Mortality from cervical cancers. |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 900000 |
| Key inclusion criteria | Women invited to routine cervical cancer screening programme within municipalities contracted |
| Key exclusion criteria | N/A |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Finland
Study participating centre
FI-00170
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | |
| 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 | |
| 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 | |
| Protocol article | protocol | 16/10/2006 | Yes | No | |
| Other publications | interim evaluation of the automation-assisted screening | 10/06/2005 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/04/2016: Plain English summary and publication reference added.
