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

Summary

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.

Conditions

• Algorithm for Cervix Carcinoma Screening

Interventions

DIAGNOSTIC_TEST

HPV DNA test with selective HPV 16/18 genotyping (cobas® 4800 HPV Test, Roche)

The enrolled patients underwent standard conventional cytology plus a test for the detection of high-risk human papilomavirus (hrHPV) with selective genotype specification (HPV 16, 18 and other hrHPV) - combined screening. In defined cases of positive hrHPV, the patient underwent reflexive examination by CINtec plus technology. After the initial combined screening the patients continued in the standard Czech screening practice (annual conventional cytology) or be treated according to the particular finding of the initial episode. For three years, the incidence of pre-cancers and invasive cervix carcinomas were monitored and data were entered into an electronic register. The second combined screening episode followed in year 3. An evaluation of its results immediately followed.

DIAGNOSTIC_TEST

p16 and Ki-67 biomarker detection in the form of dual cytological staining (CINtec Plus, Roche)

The enrolled patients underwent standard conventional cytology plus a test for the detection of high-risk human papilomavirus (hrHPV) with selective genotype specification (HPV 16, 18 and other hrHPV) - combined screening. In defined cases of positive hrHPV, the patient underwent reflexive examination by CINtec plus technology. After the initial combined screening the patients continued in the standard Czech screening practice (annual conventional cytology) or be treated according to the particular finding of the initial episode. For three years, the incidence of pre-cancers and invasive cervix carcinomas were monitored and data were entered into an electronic register. The second combined screening episode followed in year 3. An evaluation of its results immediately followed.

DIAGNOSTIC_TEST

standard conventional cytology PAP test

The enrolled patients underwent standard conventional cytology plus a test for the detection of high-risk human papilomavirus (hrHPV) with selective genotype specification (HPV 16, 18 and other hrHPV) - combined screening. In defined cases of positive hrHPV, the patient underwent reflexive examination by CINtec plus technology. After the initial combined screening the patients continued in the standard Czech screening practice (annual conventional cytology) or be treated according to the particular finding of the initial episode. For three years, the incidence of pre-cancers and invasive cervix carcinomas were monitored and data were entered into an electronic register. The second combined screening episode followed in year 3. An evaluation of its results immediately followed.

Sponsors & Collaborators

• Institute of Biostatistics and analyses, Ltd.

  collaborator UNKNOWN

• AeskuLab Pathology Prague

  lead OTHER

Principal Investigators

• Markéta Trnková, MD · Aeskulab Patologie, ks

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2018-04-20

Completion

2021-09-30

Countries

• Czechia

Study Locations