Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer (PapU-APV)
Primary Purpose
Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
vaginal auto-takings and urinary test
Sponsored by
About this trial
This is an interventional diagnostic trial for Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test focused on measuring Papillomavirus, Vaginal auto-takings, Urinary test
Eligibility Criteria
Inclusion Criteria:
- All the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest
Exclusion Criteria:
- Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.
Sites / Locations
- CHRU de Brest
- Hôpital Ferdinand Grall
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PapU-APV
Arm Description
No drug and no placebo will be used in this study. For the study participants, only their medical history data and vaginal auto-takings ( APV) and urinary will be collected.
Outcomes
Primary Outcome Measures
Research for human Papillomavirus by vaginal auto-takings and urinary test
Estimate the research for human Papillomavirus ( HPV) in the vaginal auto-takings ( APV) and urinary ( APU) test at women from 25 to 65 years old requiring a screening.
Secondary Outcome Measures
The global logistic of the study
Estimate the practicability, the organization of the screening, the follow-up of the women at the Brest Hospital and at Landerneau Hospital
Full Information
NCT ID
NCT02137694
First Posted
April 30, 2014
Last Updated
January 11, 2017
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02137694
Brief Title
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer
Acronym
PapU-APV
Official Title
Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test
Keywords
Papillomavirus, Vaginal auto-takings, Urinary test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PapU-APV
Arm Type
Other
Arm Description
No drug and no placebo will be used in this study. For the study participants, only their medical history data and vaginal auto-takings ( APV) and urinary will be collected.
Intervention Type
Other
Intervention Name(s)
vaginal auto-takings and urinary test
Intervention Description
vaginal auto-takings and urinary test
Primary Outcome Measure Information:
Title
Research for human Papillomavirus by vaginal auto-takings and urinary test
Description
Estimate the research for human Papillomavirus ( HPV) in the vaginal auto-takings ( APV) and urinary ( APU) test at women from 25 to 65 years old requiring a screening.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The global logistic of the study
Description
Estimate the practicability, the organization of the screening, the follow-up of the women at the Brest Hospital and at Landerneau Hospital
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest
Exclusion Criteria:
Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher PAYAN, PU-PH
Organizational Affiliation
CHRU Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital Ferdinand Grall
City
Landerneau
ZIP/Postal Code
29800
Country
France
12. IPD Sharing Statement
Learn more about this trial
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer
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