Brief Title
Effectiveness of Cervical Screening in HPV Vaccinated Women
Official Title
Effectiveness of Cervical Screening in HPV Vaccinated Women - A Randomized Trial
Brief Summary
The main objective of the study is to identify whether or not being informed infrequently
results about screening is: 1) At least as safe and accurate as frequently obtaining all
information from the present combination of opportunistic/organized cervical screening by
comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm
A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human
papillomavirus (HPV) vaccinated young women.
Detailed Description
Altogether 16.500 1992-1995 born women vaccinated with the bi-valent human papillomavirus
type 16 and 18 (HPV16/18) vaccine as adolescents either at the age of 12 to 15 or at the age
of 18 will be invited to an effectiveness trial at the age of 22 years, and randomized into
Arms A1 and A2, and A3, respectively.
Cervical samples and cervico-vaginal self-samples rinsed in first-void urine will be analysed
for HPV and C. trachomatis DNA with MGP primer system followed by MALDITOF mass spectrometry
on the SEQUENOM platform (HPV) and the Abbott™ PCR (Chlamydia trachomatis), respectively.
With assumed >50% participation the trial has 80% power to show non-inferiority of the
infrequent vs. the frequent screening information.
A one-way (participant) blinded interim analysis among the 1992-born study participants in A1
and A3 arms, who have attended the 2nd study visit at the age of 25 years, will be performed
in 2017 for assuring no statistically significant differences in the cervical intraepithelial
neoplasia grade 2/3 (CIN2/CIN3) incidences of the two arms.
At the study end testing the null hypotheses of no difference in the incidence of the CIN2/3
end-points between the A1 and A2 intervention arms will be done using the Mantel-Haenszel one
degree of freedom chi-square statistics.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Occurrence of intraepithelial neoplasia grade 2/3 (CIN2/3).
Condition
Cervical Intraepithelial Neoplasia Grade 2/3
Intervention
Cytological screening in A1 and A3
Study Arms / Comparison Groups
A1
Description: A1) Cytological screening in A1 and A3. Frequent information of screening results for cytology and/or HPV DNA at the ages of 22 (cytology only), 25 and 30.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
6958
Start Date
March 2014
Completion Date
January 2024
Primary Completion Date
January 2024
Eligibility Criteria
Inclusion Criteria:
- HPV 16/18 vaccinated. Born 1992-1995.
Exclusion Criteria:
- Immunocompromising disease. HPV 6/11/16/18 vaccination.
Gender
Female
Ages
22 Years - 22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Matti Lehtinen, MD, PhD, ,
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT02149030
Organization ID
HPV-004
Responsible Party
Principal Investigator
Study Sponsor
Tampere University
Collaborators
European Union
Study Sponsor
Matti Lehtinen, MD, PhD, Principal Investigator, Tampere University
Verification Date
April 2021