Neoplasms Clinical Trial
— NTCC2Official 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
Status | Not yet recruiting |
Enrollment | 60000 |
Est. completion date | December 2019 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 59 Years |
Eligibility |
Inclusion Criteria: - women invited for a new screening round based on HPV DNA test Exclusion Criteria: - women not resident in the screening area, or pregnant, or with treated CIN in the 5 previous years, or in post-colposcopy follow up, or in repetition for unsatisfactory cytology. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
Italy | Unità Locale Socio-Sanitaria 17 Este Monselice | Este | |
Italy | Istituto per lo Studio e la Prevenzione Oncologica | Florence | |
Italy | Azienda Sanitaria Locale 1-L'Aquila | L'Aquila | |
Italy | Istituto Oncologico Veneto | Padua | |
Italy | Azienda Sanitaria Locale 2- Regione Umbria | Perugia | |
Italy | Azienda Sanitaria Locale Reggio Emilia | Reggio Emilia | |
Italy | Laziosanità - Agenzia di Sanità Pubblica della Regione Lazio | Rome | |
Italy | Regina Elena Cancer Institute | Rome | |
Italy | Azienda Sanitaria Locale Roma G | Tivoli | |
Italy | Azienda Sanitaria della Provincia Autonoma di Trento | Trento | |
Italy | Centro per la Prevenzione Oncologica del Piemonte | Turin |
Lead Sponsor | Collaborator |
---|---|
Azienda Unità Sanitaria Locale Reggio Emilia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5 years | No |
Secondary | comparison between CIN2+ detection rates in the two arms in women with p16 or mRNA negative | proportion of CIN2+, HPV DNA positive and p16 or mRNA negative, which regress in a year | 1 year | Yes |
Secondary | comparison between CIN2+ detection rates in the two arms in women with negative cytology | measure of how much the cytological triage can reduce overdiagnosis compared to HPV DNA with direct sending to colposcopy | 1 year | Yes |
Secondary | comparison between CIN2+ detection rate in the two arms in women with p16 or mRNA positive | direct comparison of the effectiveness between a screening based on the HPV mRNA or p16 test followed by cytological triage and a screening with direct sending to colposcopy | 1 year | Yes |
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