Effectiveness of Cervical Screening in HPV Vaccinated Women (HPV-004)

April 27, 2021 updated by: Matti Lehtinen, Tampere University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6958

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • HUS
      • Hyvinkää, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Hämeenlinna, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Iisalmi, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Joensuu, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Jyväskylä, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Jämsä, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Kajaani, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Kemi, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Kokkola, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Kotka, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Kouvola, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Kuopio, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Lahti, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Lappeenranta, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Lohja, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Mikkeli, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Oulu, Finland
        • THL
      • Pori, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Porvoo, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Rauma, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Rovaniemi, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Salo, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Savonlinna, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Seinäjoki, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Tampere, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Turku, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Vaasa, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Vammala, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Varkaus, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto
      • Äänekoski, Finland
        • Nuorisotutkimusasema: Tampereen yliopisto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 22 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1
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.
Other: Cytological screening in A1 and A3
Cytological screening.
No Intervention: A2
A2) infrequent information of screening results, only at the age 30 years.
Other: A3
A3) Cytological screening in A1 and A3. With at least 1000 participants is enrolled for interim safety analysis when the 1992 birth cohort is 25 years of age and cytology results are being revealed.
Other: Cytological screening in A1 and A3
Cytological screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of intraepithelial neoplasia grade 2/3 (CIN2/3).
Time Frame: 2017(interim), 2026 (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).
2017(interim), 2026 (final analysis). Participants will be followed for the duration of the study until 2026, an expected average of 9 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University

Collaborators

European Union
Academy of Finland
Cancer Society of Finland

Investigators

  • Principal Investigator: Matti Lehtinen, MD, PhD, Tampere University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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