Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer (PapU-APV)

January 11, 2017 updated by: University Hospital, Brest

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.

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) .

Study Overview

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France, 29609
        • CHRU de Brest
      • Landerneau, France, 29800
        • Hôpital Ferdinand Grall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PapU-APV
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.
vaginal auto-takings and urinary test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Research for human Papillomavirus by vaginal auto-takings and urinary test
Time Frame: 6 months
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
Time Frame: 6 months
Estimate the practicability, the organization of the screening, the follow-up of the women at the Brest Hospital and at Landerneau Hospital
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christopher PAYAN, PU-PH, CHRU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test

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