MedTrace Logo

Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women (HPV400)

NCT04755517 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14000

Last updated 2025-01-13

No results posted yet for this study

Summary

To identify: 1) Whether being informed infrequently results about screening is at least as a) safe and b) accurate as frequently obtaining all information from (the present combination of opportunistic/organized) cervical screening by comparing regimen results of two screening visits at the ages of 25 and 28 years (Arm A1) vs. results of one screening visit at the age of 28 years (Arm A2) in unvaccinated herd effect protected women. Unvaccinated, frequently screened women, who are not under herd effect protection will be controls (C).

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2/3
  • Adenocarcinoma in Situ

Interventions

OTHER

Frequent information of cytological/ HPV DNA screening results

All participants will be referred to pertinent diagnosis and treatment according to local standard of care (Käypä hoito 2010) should the cytological screening results (HSIL, ASC-H, AGC-FN) or three consecutive LSIL findings at repeated control visits within 3 years indicate it. The most common screening results (ASCUS, LSIL) are, however, not convened to arm A2 participants before age 28. All cytology and HPV DNA results results are being revealed to all trial participants at age 28 at the study end.

Sponsors & Collaborators

Principal Investigators

  • Matti Lehtinen, MD, PhD · Tampere University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2025-08-31
Completion
2025-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Companies

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 NCT04755517 on ClinicalTrials.gov