HPV 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:
1. recruited women
2. HPV DNA result
3. cytology and randomization results
4. p16 result
5. mRNA result
6. colposcopies (with relative cytology and histologies) results
7. Women excluded after informed consent
8. 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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
cumulative incidence of CIN2+ in women with positive DNA and negative mRNA or p16
Sum of CIN2+ detected in women with positive DNA and negative mRNA or p16 tests during the entire period (5 years) divided by the total number of CIN2+ found in the study. The HPV DNA test will be the final follow-up test, since it is the most sensitive test among the candidates for screening, so it is the one that allows to estimate more accurately the prevalence of lesions.
Paolo Giorgi Rossi, PhD
Epidemiology Service, Local Health Authority of Reggio Emilia, Italy
Italy: Ministry of Health