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

Not Applicable

Completed

• Conditions: Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test
• Interventions: Other: vaginal auto-takings and urinary test

• Registration Number: NCT02137694
• Lead Sponsor: University Hospital, Brest

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Study Completion: 2016-10
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 460

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PapU-APV	vaginal auto-takings and urinary test	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.

Primary Outcome Measures

Name	Time	Method
Research for human Papillomavirus by vaginal auto-takings and urinary test	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.

Secondary Outcome Measures

Name	Time	Method
The global logistic of the study	6 months	Estimate the practicability, the organization of the screening, the follow-up of the women at the Brest Hospital and at Landerneau Hospital

Trial Locations

Locations (2)

Hôpital Ferdinand Grall; 🇫🇷 Landerneau, France

CHRU de Brest; 🇫🇷 Brest, France