Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
Condition: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    


Intervention name(s): Screening test
Intervention type(s): Other
Intervention description(s): Two Vaginal self sampling devices and HPV test
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Mass Screening; Polymerase Chain Reaction; Vaginal Smears