Effectiveness of Cervical Screening in HPV Vaccinated Women

Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial

— HPV-004  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02149030
• Other study ID #: HPV-004
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: January 2024

Study information

• Verified date: April 2021
• Source: Tampere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6958
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 22 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 2/3

Intervention

Other:
• Cytological screening in A1 and A3
Cytological screening.

Locations

Country	Name	City	State
Finland	Nuorisotutkimusasema: Tampereen yliopisto	Äänekoski
Finland	Nuorisotutkimusasema: Tampereen yliopisto	Hämeenlinna
Finland	HUS	Helsinki
Finland	Nuorisotutkimusasema: Tampereen yliopisto	Hyvinkää
Finland	Nuorisotutkimusasema: Tampereen yliopisto	Iisalmi
Finland	Nuorisotutkimusasema: Tampereen yliopisto	Jämsä
Finland	Nuorisotutkimusasema: Tampereen yliopisto	Joensuu
Finland	Nuorisotutkimusasema: Tampereen yliopisto	Jyväskylä
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	THL	Oulu
Finland	Nuorisotutkimusasema: Tampereen yliopisto	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

Sponsors (4)

Lead Sponsor	Collaborator
Tampere University	Academy of Finland, Cancer Society of Finland, European Union

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2017(interim), 2026 (final analysis). Participants will be followed for the duration of the study until 2026, an expected average of 9 years.