Uterine Cervical Neoplasms Clinical Trial
Official title:
Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?
Scientific Context
High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer.
Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's
well-known that this test has significantly contributed to the reduction of mortality and
morbidity due to cervical cancer. In France, it now seems that the screening strategy could
be optimized. The two main ways are to reach the 7 million underscreened women (mass
screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA
testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA
testing could be a relevant screening option: this technique appears reliable and it could
allow to reach women who are never or seldom screened. Currently, there is no French data on
the SCVS for HPV DNA testing.
The goal of this study is to determine the performance and acceptability of a
population-based strategy using self-collected vaginal samples for HPV DNA testing to reach
women who are not participating in cervical cancer screening.
Description of the project
This project (APACHE-1) is a part of a project called APACHE. APACHE-1 will be dedicated to
the SCVS technical validation and to the comparison between different transports medium.
Nine hundred women will be recruited from the 20 to 65 years consultants in the Tours
University Hospital (CHRU of Tours) and in the IRSA (health centre for routine medical
checkup).
Each woman will collect 2 SCVS with a nylon flocked swab (Copan® microRheologics™). The
first SCVS will be put in a vial which contains a liquid medium. The second SCVS will be put
in a dry vial. Then during the speculum examination the physician will collect a cervical
sample with a Rovers® Cervex-Brush™ and then rinse it into a vial containing PréservCyt ™. A
blind HPV DNA testing and genotyping (Inno-LIPA HPV Genotyping ™ Extra) will be performed in
the virology laboratory of the CHRU of Tours on all samples (SCVSs and cervical samples
performed by a physician). The performance of the SCVS to detect cervical HPV infection will
be assessed (gold standard test = HPV DNA testing on cervical samples collected by the
physician).
In a second time (APACHE-2), the researchers will investigate to what extent offering home
obtained SCVS leads to participation of unscreened women. APACHE-2 will be registered on
Clinicaltrials as another project.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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