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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014026
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : May 13, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Uterine Cervical Dysplasia Other: Screening test Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 734 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?
Study Start Date : September 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Intervention Details:
  • Other: Screening test
    Two Vaginal self sampling devices and HPV test

Primary Outcome Measures :
  1. Concordance between the three HPV tests [ Time Frame: End of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014026

La Riche, France, 37521
Le Mans, France, 72000
Service d'Orthogénie, CHRU Tours
Tours, France, 37000
Service de Gynécologie, CHRU Tours
Tours, France, 37000
Association Paul Metadier
Tours, France
Sponsors and Collaborators
University Hospital, Tours
Study Director: Ken HAGUENOER François Rabelais University, Public Health Laboratory, Tours, France

Responsible Party: University Hospital, Tours Identifier: NCT01014026     History of Changes
Other Study ID Numbers: INCA08-KH/APACHE-1
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: May 2011

Keywords provided by University Hospital, Tours:
Mass Screening
Polymerase Chain Reaction
Vaginal Smears

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type