Brief Title
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
Official Title
Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Concordance between the three HPV tests
Condition
Uterine Cervical Neoplasms
Intervention
Screening test
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
734
Start Date
September 2009
Completion Date
March 2011
Primary Completion Date
March 2011
Eligibility Criteria
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
Gender
Female
Ages
20 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Ken HAGUENOER, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01014026
Organization ID
INCA08-KH/APACHE-1
Study Sponsor
University Hospital, Tours
Study Sponsor
Ken HAGUENOER, Study Director, François Rabelais University, Public Health Laboratory, Tours, France
Verification Date
May 2011