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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01014026
First received: November 13, 2009
Last updated: May 12, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
 Other: Screening test
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Concordance between the three HPV tests [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Enrollment: 734
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Screening test
    Two Vaginal self sampling devices and HPV test
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014026

Locations
France
IRSA 37
La Riche, France, 37521
IRSA 72
Le Mans, France, 72000
Service de Gynécologie, CHRU Tours
Tours, France, 37000
Service d'Orthogénie, CHRU Tours
Tours, France, 37000
Association Paul Metadier
Tours, France
Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: Ken HAGUENOER François Rabelais University, Public Health Laboratory, Tours, France
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01014026     History of Changes
Other Study ID Numbers: INCA08-KH/APACHE-1
Study First Received: November 13, 2009
Last Updated: May 12, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Neoplasms
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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013