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Trial23 - A Method Study on Cervical Screening in Women Offered HPV-vaccination as Girls

NCT03049553 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7000

Last updated 2022-11-04

No results posted yet for this study

Summary

In Denmark, the first birth cohorts of women offered HPV-vaccination as girls are entering the cervical screening program. These women are expected to be better protected against cervical cancer. It has not yet been decided how to screen these women.

This method study will investigate a possible screening scheme that could provide a reduced burden of screening for HPV-vaccinated birth cohorts.

Conditions

  • Cervical Intraepithelial Neoplasia (CIN)

Interventions

DEVICE

Cobas HPV-DNA test

Cobas HPV-DNA testing device from Roche is already in standard use in the Danish screening program for purpose of triage and primary screening of women 60+. It has four signals; HPV-negative, HPV-16, HPV-18 and "other"

Sponsors & Collaborators

  • Naestved Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Soenderjylland Hospital

    collaborator UNKNOWN

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Randers Regional Hospital

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Elsebeth Lynge, Professor · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049553 on ClinicalTrials.gov