Trial Title:
Cervical Cancer Prevention: From DNA to mRNA? - New Technologies for Cervical Cancer Screening 2
NCT ID:
NCT01837693
Condition:
Precancerous Conditions
Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Precancerous Conditions
Conditions: Keywords:
cervical cancer screening
CIN
cervical cancer
biomarkers
sensitivity and specificity
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Experimental: immediate colposcopy
Description:
A immediate colposcopy in this arm may detect potentially spontaneous regressive cervical
lesions, so may determine an over diagnosis and over treatment, which the study want to
estimate
Arm group label:
direct sending in colposcopy
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 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
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
25 Years
Maximum age:
59 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Unità Locale Socio-Sanitaria 17 Este Monselice
Address:
City:
Este
Country:
Italy
Investigator:
Last name:
Antonio Ferro
Email:
Principal Investigator
Facility:
Name:
Istituto per lo Studio e la Prevenzione Oncologica
Address:
City:
Florence
Country:
Italy
Investigator:
Last name:
Francesca Carozzi
Email:
Principal Investigator
Investigator:
Last name:
Massimo Confortini
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Locale 1-L'Aquila
Address:
City:
L'Aquila
Country:
Italy
Investigator:
Last name:
Vincenzo Maccallini
Email:
Principal Investigator
Facility:
Name:
Istituto Oncologico Veneto
Address:
City:
Padua
Country:
Italy
Facility:
Name:
Azienda Sanitaria Locale 2- Regione Umbria
Address:
City:
Perugia
Country:
Italy
Investigator:
Last name:
Basilio Passamonti
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Locale Reggio Emilia
Address:
City:
Reggio Emilia
Country:
Italy
Investigator:
Last name:
Luisa Paterlini
Email:
Principal Investigator
Facility:
Name:
Laziosanità - Agenzia di Sanità Pubblica della Regione Lazio
Address:
City:
Rome
Country:
Italy
Facility:
Name:
Regina Elena Cancer Institute
Address:
City:
Rome
Country:
Italy
Facility:
Name:
Azienda Sanitaria Locale Roma G
Address:
City:
Tivoli
Country:
Italy
Investigator:
Last name:
Maria Concetta Tufi
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria della Provincia Autonoma di Trento
Address:
City:
Trento
Country:
Italy
Investigator:
Last name:
Paolo Dalla Palma
Email:
Principal Investigator
Facility:
Name:
Centro per la Prevenzione Oncologica del Piemonte
Address:
City:
Turin
Country:
Italy
Investigator:
Last name:
Guglielmo Ronco
Email:
Principal Investigator
Start date:
June 2013
Completion date:
December 2019
Lead sponsor:
Agency:
Azienda Unità Sanitaria Locale Reggio Emilia
Agency class:
Other
Source:
Azienda Unità Sanitaria Locale Reggio Emilia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01837693
