Clinical trial NCT01014026: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Keywords: Mass Screening
Polymerase Chain Reaction
Vaginal Smears
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2009-11-16
Enrollment: 734
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Concordance between the three HPV tests
timeFrame: End of the study
Secondary outcomes:
Other outcomes:
Locations:
city: La Riche
country: France
facility: IRSA 37
city: Le Mans
country: France
facility: IRSA 72
city: Tours
country: France
facility: Service d'Orthogénie, CHRU Tours
city: Tours
country: France
facility: Service de Gynécologie, CHRU Tours
city: Tours
country: France
facility: Association Paul Metadier
Study officials:
affiliation: François Rabelais University, Public Health Laboratory, Tours, France
name: Ken HAGUENOER
role: STUDY_DIRECTOR
References: