Algorithm for Cervix Carcinoma Screening in CZ Using the Detection of HPV DNA and CINtec Plus (LIBUSE)

October 11, 2022 updated by: AeskuLab Pathology Prague

Algorithm for Cervix Carcinoma Screening in the Czech Republic Using the Detection of HPV DNA With Selective HPV 16/18 Genotype and Special CINtec Plus Cytological Colouring

Cervix carcinoma has been a serious, long-term issue in the Czech Republic. The cause of nearly all cervix carcinomas is human papilomavirus (HPV). Hence the detection of the HPV genome is a more prospective screening tool with higher sensitivity than a cytological swab. As shown by comparative studies, the sensitivity of the HPV DNA test in the detection of severe pre-cancer is 35% higher on average when compared to the cytological test.

The study repeatedly determined the presence of the HPV genome, including the prevalence of selected HPV genotypes (16, 18 and other hrHPV) and conventional cytology. The relative sensitivity of the two methods was specified. In the course of the prospective follow-up, the incidence of pre-cancers and invasive tumours in the study population were specified.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cervix carcinoma has been a serious, long-term issue in the Czech Republic. About 1,000 new cases are diagnosed every year and about 400 female patients die as a result of the disease. More than 20,000 women in the Czech Republic live with a history of cervix carcinoma therapy and the potential risk of its recurrence. Although the past years have been marked with effective organisational changes in cervix carcinoma screening thanks to which a decreasing trend of its incidence can be observed, there is a lack of substantial impact on the occurrence of advanced stages of the disease and mortality. Similar data have also been reported internationally: foreign authors analysed cases of patients with a malignant cervix tumour. They reported that 24 - 32% of females with a diagnosed malignant tumour had periodically undergone cytological screening. The reason is that the sensitivity of an individual cytological examination for detecting severe pre-cancer is limited, ranging between 40 - 75% and only increasing with repeated examinations. The negative predictive value of the cytological swab is additionally limited and reaches 0.78% in recent studies over a three-year screening interval.

The cause of nearly all cervix carcinomas is human papilomavirus (HPV). Hence the detection of the HPV genome is a more prospective screening tool with higher sensitivity than a cytological swab. The sensitivity of the validated HPV DNA test using PCR method reaches 94.5% for detecting severe pre-cancer (confidence interval 94.2 - 96.9%). As shown by comparative studies, the sensitivity of the HPV DNA test for the detection of severe pre-cancer is 35% higher on average when compared to the cytological test. The HPV DNA test in addition shows a significantly better negative three-year predictive value (0.34%) and the low value continues for at least another five years. The lower specificity of the HPV DNA test can be compensated by selective genotype specification with proof of the most frequent oncogenic genotypes HPV 16 and HPV 18. This promising procedure, validated by large multicentric randomised studies and introduced to clinical practice in several European countries, primarily uses the detection of HPV DNA.

The study repeatedly determined the presence of the HPV genome, including the prevalence of selected HPV genotypes (16, 18 and other hrHPV) and conventional cytology. The relative sensitivity of the two methods was specified. In the course of the prospective follow-up, the incidence of pre-cancers and invasive tumours in the study population were specified.

Study Type

Observational

Enrollment (Actual)

2426

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Praha, Czech Republic, Czechia, 160 00
        • Aeskulab Patologie, ks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females 30 - 60 years

Description

Inclusion Criteria:

  • Informed consent signature
  • Age 30 - 60
  • Screening (not reviewing after previous abnormal cytological finding)
  • Sampling of gravid women possible

Exclusion Criteria:

  • Refusal to take part

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of hrHPV positivity in the Czech population
Time Frame: 49 months
The ratio of patients with a positive HPV test in the first combined screening episode and the number of examined women.
49 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specification of prevalence of selected hrHPV genotypes
Time Frame: 49 months
Representation of individual hrHPV genotypes in the first and the second screening episode in all examined women and in all HPV positive women.
49 months
Detection level of pre-cancers and invasive carcinomas in the first combined screening episode (indicator of relative sensitivity of the two methods)
Time Frame: 49 months
The ratio of detected diseases and the number of examined women in the first screening episode, a secondary endpoint.
49 months
Incidence of pre-cancers and invasive carcinomas in the course of the follow-up
Time Frame: 49 months
The cumulative incidence of diseases considering the censored patients, a secondary endpoint.
49 months
Incidence of pre-cancers and invasive carcinomas after the second screening episode
Time Frame: 49 months
The cumulative incidence of the disease in patients based on the initial HPV test results and initial cytology results.
49 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AeskuLab Pathology Prague

Collaborators

Institute of Biostatistics and analyses, Ltd.

Investigators

  • Principal Investigator: Markéta Trnková, MD, Aeskulab Patologie, ks

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

April 20, 2018

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBA1132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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