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

2019-10-08 08:47:41 | BioPortfolio

Summary

The HIPPOPROJECT 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.

Description

The study assumes randomized assumption of 33,000 women aged 30-59 to cytology or HR HPV test in a 1:1 ratio with age stratification (three strata: 30-39, 40-49 and 50-59 years).

The study will start on September 2019 at the Department of Cervical Cancer Prevention at the Maria Sklodowska-Curie Cancer Center and Institute of Oncology in Warsaw. To obtain results representative for the entire country several sites are planned for inclusion in the study from 2020 in 6 regions of Poland.

Primary end-points include the detection rate of histologically confirmed high grade intraepithelial lesions or worse in each screening arm. Selected secondary endpoints include detection rate ratios, colposcopy referral rates and positive predictive values of referral for colposcopy.

The study has been approved by a local bioethics committee.

Study Design

Conditions

Cervical Cancer

Intervention

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

Location

Maria Sklodowska-Curie Institute - Oncology Center
Warsaw
Poland

Status

Not yet recruiting

Source

Maria Sklodowska-Curie Institute - Oncology Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-08T08:47:41-0400

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