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

Primary Purpose

Cervical Intraepithelial Neoplasia Grade 2/3

Status
Active
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Cytological screening in A1 and A3
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Intraepithelial Neoplasia Grade 2/3

Eligibility Criteria

22 Years - 22 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • HUS
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • THL
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto
  • Nuorisotutkimusasema: Tampereen yliopisto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Other

Arm Label

A1

A2

A3

Arm 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.

A2) infrequent information of screening results, only at the age 30 years.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 19, 2014
Last Updated
April 27, 2021
Sponsor
Tampere University
Collaborators
European Union, Academy of Finland, Cancer Society of Finland
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1. Study Identification

Unique Protocol Identification Number
NCT02149030
Brief Title
Effectiveness of Cervical Screening in HPV Vaccinated Women
Acronym
HPV-004
Official Title
Effectiveness of Cervical Screening in HPV Vaccinated Women - A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
European Union, Academy of Finland, Cancer Society of Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia Grade 2/3

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6958 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm 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.
Arm Title
A2
Arm Type
No Intervention
Arm Description
A2) infrequent information of screening results, only at the age 30 years.
Arm Title
A3
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cytological screening in A1 and A3
Intervention Description
Cytological screening.
Primary Outcome Measure Information:
Title
Occurrence of intraepithelial neoplasia grade 2/3 (CIN2/3).
Description
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(interim), 2026 (final analysis). Participants will be followed for the duration of the study until 2026, an expected average of 9 years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: HPV 16/18 vaccinated. Born 1992-1995. Exclusion Criteria: Immunocompromising disease. HPV 6/11/16/18 vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti Lehtinen, MD, PhD
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUS
City
Helsinki
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Hyvinkää
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Hämeenlinna
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Iisalmi
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Joensuu
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Jyväskylä
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Jämsä
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Kajaani
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Kemi
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Kokkola
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Kotka
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Kouvola
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Kuopio
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Lahti
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Lappeenranta
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Lohja
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Mikkeli
Country
Finland
Facility Name
THL
City
Oulu
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Pori
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Porvoo
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Rauma
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Rovaniemi
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Salo
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Savonlinna
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Seinäjoki
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Tampere
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Turku
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Vaasa
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Vammala
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Varkaus
Country
Finland
Facility Name
Nuorisotutkimusasema: Tampereen yliopisto
City
Äänekoski
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Cervical Screening in HPV Vaccinated Women

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