- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02137694
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
Status
Completed
Intervention / Treatment
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
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Brest, France, 29609
- CHRU de Brest
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Landerneau, France, 29800
- Hôpital Ferdinand Grall
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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.
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vaginal auto-takings and urinary test
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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.
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6 months
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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
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RB 13.161 PapU-APV
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.
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