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NCT Number: NCT02149030

Effectiveness of Cervical Screening in HPV Vaccinated Women

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3

Age range

22 year–22 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HUS, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HPV 16/18 vaccinated. Born 1992-1995.

Exclusion criteria

  • Immunocompromising disease. HPV 6/11/16/18 vaccination.

Treatment and study plan

Cytological screening in A1 and A3

Other

Cytological screening.

Primary outcomes

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

    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.

    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).

Secondary outcomes

  1. Type-replacement

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

    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.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Academy of Finland
  • Cancer Society of Finland
  • European Union

Registry information

Official study title

Effectiveness of Cervical Screening in HPV Vaccinated Women - a Randomized Trial

Acronym: HPV-004

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
May 29, 2014
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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