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

CompletedOBSERVATIONAL
Enrollment

2,426

Participants

Timeline

Start Date

September 1, 2017

Primary Completion Date

April 20, 2018

Study Completion Date

September 30, 2021

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."

Trial Locations (1)

160 00

Aeskulab Patologie, ks, Prague

All Listed Sponsors
collaborator

Institute of Biostatistics and analyses, Ltd.

UNKNOWN

lead

AeskuLab Pathology Prague

OTHER

NCT05578833 - Algorithm for Cervix Carcinoma Screening in CZ Using the Detection of HPV DNA and CINtec Plus | Biotech Hunter | Biotech Hunter