Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention (APACHE-1)
Primary Purpose
Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Screening test
Sponsored by
About this trial
This is an interventional diagnostic trial for Uterine Cervical Neoplasms focused on measuring Mass Screening, Polymerase Chain Reaction, Vaginal Smears
Eligibility 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
Sites / Locations
- IRSA 37
- IRSA 72
- Service d'Orthogénie, CHRU Tours
- Service de Gynécologie, CHRU Tours
- Association Paul Metadier
Outcomes
Primary Outcome Measures
Concordance between the three HPV tests
Secondary Outcome Measures
Full Information
NCT ID
NCT01014026
First Posted
November 13, 2009
Last Updated
May 12, 2011
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT01014026
Brief Title
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
Acronym
APACHE-1
Official Title
Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
Keywords
Mass Screening, Polymerase Chain Reaction, Vaginal Smears
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
734 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Screening test
Intervention Description
Two Vaginal self sampling devices and HPV test
Primary Outcome Measure Information:
Title
Concordance between the three HPV tests
Time Frame
End of the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken HAGUENOER
Organizational Affiliation
François Rabelais University, Public Health Laboratory, Tours, France
Official's Role
Study Director
Facility Information:
Facility Name
IRSA 37
City
La Riche
ZIP/Postal Code
37521
Country
France
Facility Name
IRSA 72
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Service d'Orthogénie, CHRU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Service de Gynécologie, CHRU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Association Paul Metadier
City
Tours
Country
France
12. IPD Sharing Statement
Learn more about this trial
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
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