Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer

Study Overview
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Brief Summary
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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) .

Official Title
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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.

Conditions
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Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test

Intervention / Treatment
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* Other: vaginal auto-takings and urinary test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PapU-APV<br>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. | Other: vaginal auto-takings and urinary test<br>* vaginal auto-takings and urinary test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal auto-takings, Papillomavirus, Urinary test