NTCC2HPV as Primary Screening Test in Cervical Cancer Prevention: From DNA to mRNA? A Randomised Controlled Trial Nested in a Double Testing Study With Long Term Follow up

Individual data about the following study steps are collected according a fixed format: recruited women HPV DNA result cytology and randomization results p16 result mRNA result colposcopies (with relative cytology and histologies) results Women excluded after informed consent Interventions During the first year of recruitment, there will be two semi-annual sending of data, then each year. To analyze the study progress in each center, summary tables will periodically send to the PI. All CIN lesions and cancers found in the study will be be blindly reviewed. A set of quality assurance procedures will be implemented for both the molecular tests, including the use of controls provided by the manufacturers with known HPV DNA or mRNA content and the circulation of clinical samples prepared by the laboratories participating in the study.