Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm
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|ClinicalTrials.gov Identifier: NCT01511328|
Recruitment Status : Unknown
Verified March 2017 by Joakim Dillner, Karolinska Institutet.
Recruitment status was: Active, not recruiting
First Posted : January 18, 2012
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|High-grade Cervical Intraepithelial Neoplasia||Other: HPV testing||Not Applicable|
Primary HPV screening is a method with higher sensitivity than cytology for detection of high-grade cervical intraepithelial neoplasia, which is the precursor of cervical cancer. In particular, HPV test is a better test for revealing adenocarcinomas, since these cancers often show a normal cytology.
Cervical cancer screening at age 60:
Cytology is less effective in older women, and screening with cytology in women over 60 has no documented effect. Today a large part of cervical cancer develop in women older than 60, to whom no screening is offered. The prevalence of HPV is around 4% in this age group. Since we know that testing negative for HPV gives a better long-term protection against cervical cancer compared to cytology, primary screening for HPV in 60-year old women would give a longer lasting protection in this high-risk group compared with today.
Cervical cancer screening at age 30-40:
HPV screening is most cost effective above 35 years of age. The reason for this is that HPV is less prevalent at age 35 than in younger women and also because cervical cancer seldom develops before this age. Since the HPV test has a negative predictive value (NPV) of almost 100% this could lead to longer screening intervals, which would be improve cost-effectiveness.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: HPV testing
Women randomised to this arm get primary HPV testing
Other: HPV testing
Testing for Human Papilloma Virus
No Intervention: cytology
women included follow the standard procedure with primary cytology
- number of CIN 2+ cases for the two different diagnostic procedures [ Time Frame: first evaluation, the 1 of january 2013 ]The number of women with CIN2+ detected by primary HPV testing will be compared with the number of women with CIN2+ detected by primary cytology
- calculation of cost for the two different diagnostic procedures [ Time Frame: first evaluation, 1 of January 2013 ]The cost for the new procedure with HPV test in primary screening will be compared to the routine procedure with primary cytology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511328
|Karolinska University Hospital|
|Stockholm, Sweden, 141 86|
|Principal Investigator:||Joakim Dillner, MD, PhD||Karolinska Institutet|