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Spots Global Cancer Trial Database for Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm

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Trial Identification

Brief Title: Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm

Official Title: Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm

Study ID: NCT01511328

Interventions

HPV testing

Study Description

Brief Summary: The purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.

Detailed Description: 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. 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. 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.

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Karolinska University Hospital, Stockholm, , Sweden

Contact Details

Name: Joakim Dillner, MD, PhD

Affiliation: Karolinska Institutet

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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