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

Regional University Hospital Center (CHRU)

Status: Completed

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

Treatments: Other: vaginal auto-takings and urinary test

Study type: Interventional

Funder types: Other

Identifiers

NCT02137694

RB 13.161 PapU-APV

Details and patient eligibility

About

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) .

Enrollment: 460 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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460 participants in 1 patient group

PapU-APV

Other group

Description:

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.

Treatment:

Other: vaginal auto-takings and urinary test