Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention (APACHE-1)
|ClinicalTrials.gov Identifier: NCT01014026|
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : May 13, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Neoplasms Uterine Cervical Dysplasia||Other: Screening test||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||734 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
- Other: Screening test
Two Vaginal self sampling devices and HPV test
- Concordance between the three HPV tests [ Time Frame: End of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014026
|La Riche, France, 37521|
|Le Mans, France, 72000|
|Service d'Orthogénie, CHRU Tours|
|Tours, France, 37000|
|Service de Gynécologie, CHRU Tours|
|Tours, France, 37000|
|Association Paul Metadier|
|Study Director:||Ken HAGUENOER||François Rabelais University, Public Health Laboratory, Tours, France|