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HPV Testing In Polish POpulation-based Cervical Cancer Screening Program.

NCT04111835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33000

Last updated 2024-02-02

No results posted yet for this study

Summary

The HIPPO PROJECT is a randomized healthcare study nested in the OCCSP in Poland. This project will assess the performance of the new screening test (HR HPV test) before its implementation in Poland.

Conditions

Interventions

DIAGNOSTIC_TEST

Offering an alternative cervical cancer screening method - hrHPV molecular testing.

Women randomized to this screening strategy group will take a hrHPV molecular test. hrHPV-positive - reflex LBC: Abnormal reflex LBC (ASC-US or worse) -\> colposcopy Normal reflex LBC -\> repeat LBC in 6 months Positive - colposcopy Negative - rescreen in 3 years HPV-negative - rescreen in 5 years

Sponsors & Collaborators

  • Ministry of Health, Poland

    collaborator OTHER_GOV

  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2022-11-03
Completion
2023-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04111835 on ClinicalTrials.gov