Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
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.
Inclusion Criteria:

 -  Women between 20 and 65

 Exclusion Criteria:

 -  Menstruation

 -  pregnant

 -  Inability to give informed consent

 -  Vaccinated against HPV 16 and 18

 -  Total Hysterectomy

 -  treatment of CIN 1, 2 or 3

 -  Abnormal smear in the past year

 -  Smear in the past 2 years

 -  Virgin