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

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

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137694
• Other study ID #: RB 13.161 PapU-APV
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: January 11, 2017
• Start date: April 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test
• Uterine Cervical Neoplasms

Intervention

Other:
• vaginal auto-takings and urinary test
vaginal auto-takings and urinary test

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	Hôpital Ferdinand Grall	Landerneau

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No