Neoplasms Clinical Trial
Official title:
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
In industrialized countries, cervical cancer is a well controlled disease thanks to the
diffusion of Pap test and, in particular, to organized screening programs, which are able to
detect and treat pre-invasive lesions (cervical intraepithelial neoplasia, CIN). The human
papilloma virus (HPV) has been recognised as the necessary, but not sufficient, cause of
cervical cancer, so a new screening test based on the identification of high risk (HR) HPV
types has been developed(HPV DNA test). This test has demonstrated to be more effective than
cytology in reducing the incidence and the mortality of cervical cancer, but it is less
specific, so the use of a test triage is necessary to reduce the number of colposcopies and
the risk of over-diagnosis (due to the potential regressivity of pre-invasive lesions).
Until now, the triage test used is the cytology (Pap test).
Recently specific biomarkers (mRNA and p16 tests) have been introduced for high grade CIN,
targeting the molecular alterations strictly associated to transformation rather than simply
detecting HR-HPV infections. These tests are more specific than HPV DNA test with a modest
reduction of sensitivity for high-grade lesions.
This is a multicenter randomised trial nested into some Italian screening programs based on
the use of HPV DNA test as primary test.
All women with positive HPV DNA test will be tested for cytology and also for mRNA and p16.
Women with positive cytology will be referred to colposcopy, while women with negative
cytology will be randomized into two arms.
This study aims to evaluate if mRNA and p16 could be used as test of triage of HPV DNA or as
a primary screening test with direct sending in colposcopy.
In particular the main objectives are:
- Measuring the cumulative detection rate of CIN2+ in the five years following a HPV DNA
positive test and mRNA or p16 negative.
- Measuring the potential reduction of overdiagnosis of using mRNA or p16 test instead of
DNA, with direct sending in colposcopy
- Measuring the reduction of overdiagnosis of cytological triage or triage with mRNA or
p16 compared to the direct sending in colposcopy in women with HPV DNA test positive.
Secondary objectives are:
- to assess the feasibility of mRNA testing in primary screening
- to validate the sample techniques for the new tests
- to standardize quality controls for the the new tests
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
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