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

NCT01014026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 734

Last updated 2011-05-13

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia

Interventions

OTHER

Screening test

Two Vaginal self sampling devices and HPV test

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Ken HAGUENOER · François Rabelais University, Public Health Laboratory, Tours, France

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014026 on ClinicalTrials.gov