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56 Years
65 Years
Not Enrolling
High-grade Cervical Intraepithelial Neoplasia

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Trial Information

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

Inclusion Criteria:

- women between the age 56 and 65 years

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

number of CIN 2+ cases for the two different diagnostic procedures

Outcome Description:

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

Outcome Time Frame:

first evaluation, the 1 of january 2013

Safety Issue:


Principal Investigator

Joakim Dillner, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska Institutet


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • High-grade Cervical Intraepithelial Neoplasia
  • HPV testing
  • Primary screening
  • Cervical Cancer
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ