Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention (APACHE-1)

May 12, 2011 updated by: University Hospital, Tours

Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

734

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Riche, France, 37521
        • IRSA 37
      • Le Mans, France, 72000
        • IRSA 72
      • Tours, France, 37000
        • Service d'Orthogénie, CHRU Tours
      • Tours, France, 37000
        • Service de Gynécologie, CHRU Tours
      • Tours, France
        • Association Paul Metadier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concordance between the three HPV tests
Time Frame: End of the study
End of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Ken HAGUENOER, François Rabelais University, Public Health Laboratory, Tours, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (Estimate)

November 16, 2009

Study Record Updates

Last Update Posted (Estimate)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA08-KH/APACHE-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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