Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01837693
Status:
UNKNOWN
Last Update Posted:
2013-04-23
First Post:
2013-04-18
Brief Title:
Cervical Cancer Prevention From DNA to mRNA - New Technologies for Cervical Cancer Screening 2
Sponsor:
Azienda Unità Sanitaria Locale Reggio Emilia
Organization:
Azienda Unità Sanitaria Locale Reggio Emilia
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NTCC2
Brief Summary:
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 developedHPV 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None