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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

6,958

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach

1 country

31 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10.8 years study duration

Study Start

First participant enrolled

March 1, 2014

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed

10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed

10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed

Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

10.8 years

First QC Date

May 19, 2014

Last Update Submit

January 15, 2025

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3

Outcome Measures

Primary Outcomes (1)

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).
2017-2020, 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 (1)

Type-replacement
2021-2025, i.e. four years

Study Arms (3)

A1

ACTIVE COMPARATOR

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

A2

NO INTERVENTION

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

A3

OTHER

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

Interventions

Cytological screening in A1 and A3OTHER

Cytological screening.

A1A3

Eligibility Criteria

Age22 Years - 22 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

HPV 16/18 vaccinated. Born 1992-1995.

You may not qualify if:

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

Contact the study team to confirm eligibility.