Effectiveness of Cervical Screening in HPV Vaccinated Women

N/AActive Not RecruitingNCT02149030

Tampere University6,958 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

6,958

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3

Interventions

Cytological screening in A1 and A3OTHER

Cytological screening.

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * HPV 16/18 vaccinated. Born 1992-1995. Exclusion Criteria: * Immunocompromising disease. HPV 6/11/16/18 vaccination.

Locations (31)

Outcomes

Primary Outcomes

Occurrence of intraepithelial neoplasia grade 2/3 (CIN2/3).

1a) No marked difference in the incidence of CIN2/3 between arms A1 (participants frequently informed of the cytological results) and A3 (participants not informed of the cytological findings at the age of 22) (interim analysis). 1b) No difference in the incidence of CIN2/3 between arms A1 (participants frequently informed of the cytological results) and A2 (participants infrequently informed of the cytological results). The participants will be followed for 9 years starting from the year they turn 22. For 1992 born the follow-up will start in 2014 and end in 2023. For 1995 born the follow-up will start in 2017 and end in 2026. The interim analysis will include only 1992 cohort. The final analysis will include all cohorts (1992, 1993, 1994, 1995).

Time frame: 2017-2020, i.e. four years (interim), 2021-2025, i.e. five years (final analysis). Participants will be followed for the duration of the study until 2026, an expected average of 9 years.

Secondary Outcomes

Type-replacement

Whether the post-vaccination distributions of vaccine-covered and/or non-vaccine covered HPV types develop differentially in the different vaccination arms by vaccination arm over time up to 15 years post vaccination.

Time frame: 2021-2025, i.e. four years

Data from ClinicalTrials.gov

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