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

Phase 3

Completed

• Conditions: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

• Registration Number: NCT01014026
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 734

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Concordance between the three HPV tests	End of the study

Trial Locations

Locations (5)

IRSA 37; 🇫🇷 La Riche, France

Service d'Orthogénie, CHRU Tours; 🇫🇷 Tours, France

Association Paul Metadier; 🇫🇷 Tours, France

Service de Gynécologie, CHRU Tours; 🇫🇷 Tours, France

IRSA 72; 🇫🇷 Le Mans, France