Clinical trial NCT05578833: Algorithm for Cervix Carcinoma Screening in CZ Using the Detection of HPV DNA and CINtec Plus
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Algorithm for Cervix Carcinoma Screening
Keywords: HPV DNA
LIBUSE
CINtec plus
cytology
cervix carcinoma
human papilomavirus
Lead sponsor: AeskuLab Pathology Prague
Sponsor class: OTHER
Collaborators: name: Institute of Biostatistics and analyses, Ltd.
First posted: 2022-10-13
Enrollment: 2426
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females 30 - 60 years

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of hrHPV positivity in the Czech population
timeFrame: 49 months
Secondary outcomes:
measure: Specification of prevalence of selected hrHPV genotypes
timeFrame: 49 months
measure: Detection level of pre-cancers and invasive carcinomas in the first combined screening episode (indicator of relative sensitivity of the two methods)
timeFrame: 49 months
measure: Incidence of pre-cancers and invasive carcinomas in the course of the follow-up
timeFrame: 49 months
measure: Incidence of pre-cancers and invasive carcinomas after the second screening episode
timeFrame: 49 months
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Aeskulab Patologie, ks
state: Czech Republic
Study officials:
affiliation: Aeskulab Patologie, ks
name: Markéta Trnková, MD
role: PRINCIPAL_INVESTIGATOR
References:
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