2,426
Participants
Start Date
September 1, 2017
Primary Completion Date
April 20, 2018
Study Completion Date
September 30, 2021
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."
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."
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."
Aeskulab Patologie, ks, Prague
Institute of Biostatistics and analyses, Ltd.
UNKNOWN
AeskuLab Pathology Prague
OTHER