Urinary Human Papilloma Virus Test in the General Population in Brittany

Not Applicable

• Conditions: Neoplasms,Ovarian
• Interventions: Device: Urinary test

• Registration Number: NCT03598946
• Lead Sponsor: University Hospital, Brest

Brief Summary

This is a population-based, prospective, multicenter and open-label study. 12,500 female non-respondents to the uterine cervix smear from 30 to 65 years of age in the context of the organized cervical cancer screening of the uterus, in the 4 Breton departments, will be proposed after stratification by age and socio-economic level at the revival of the cervical cancer of the uterus screening by the structure of management of Rennes, an invitation to the Human Papilloma Virus urine test thanks to the sampling kit sent to the home. It is planned a revival by simple mail after 4 months in one woman out of two who did not respond to this invitation to assess the impact of a recovery. This group represents about 5% of the eligible population in Brittany. The specimen will be sent by post with the signed consent and a questionnaire to the Hospital of Brest in virology laboratory for the detection of Human Papilloma Virus DNA (QPCR) in the urine (HPU test) and typing (LipA). In the case of a positive Human Papilloma Virus test, the woman being tested has a strong incentive to do the cervical cancer of the uterus with her doctor or midwife. In the case of abnormal smear, follow-up continues according to national recommendations to a gynecologist. All the data is collected on a software from the LINKS company, with the networking of the 4 Breton centers, the virology laboratory, and the Anatomy-Cytology-Pathology laboratories in Brittany; this collection will allow after extraction, a statistical analysis of the data. The analysis of the participation rate in this new screening, for each level of the socio-economic level, will allow a comparison with the participation in smear's revival of organized screening, between women's groups according to the socio-economic level of their residential place.

The project will take place over 24 months in 3 phases:

1. D0-M6: Pre-inclusion phase with implementation of the protocol (regulatory procedures, production of newsletters, consent, questionnaire, preparation of urine collection kits, postal validation).

2. M6-M18: Inclusion phase with start of the study, sending invitations and inclusion, Human Papillomavirus Urinary testing and uterine cervix smear monitoring.

3. M18-M24: Post-inclusion phase with assessment of the inclusions on the 4 Breton departments, verification and analysis of the data according to the socio-economic level, recovery of the uterine cervix smear stimulus data, realization of the statistical analyzes and budget impact analysis, communications and publications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Study Start: 2021-04-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15
• Primary Completion: 2022-10-29
• Study Completion: 2023-10-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12500

Inclusion Criteria

• Women from 30 to 65 years old who did not do uterine cervix smear and who live in Brittany

Exclusion Criteria

• Women under 30 years or over 65 years
• Women of 30-65 years who have responded to the uterine cervix smear invitation
• Women who have had an uterine cervix smear raise
• Women who have already had an uterine cervix smear within 3 years
• Women who had a total hysterectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human Papilloma Virus Test urinary	Urinary test	Urinary Test by a kit which is send to the woman's house

Primary Outcome Measures

Name	Time	Method
Rate of participation in the urinary group	18 months	To evaluate the rate of participation in the urinary test group

Secondary Outcome Measures

Name	Time	Method
Participation rate by different parameters	18 months	To evaluate the participation rate
Evaluation of access of the medical network with different indicators	18 months	To evaluate the access to the medical network
Evaluation of the Papillomavirus levels of genotype 16 and genotype 18 in the population	18 months	To evaluate the Papillomavirus levels of genotype 16 and genotype 18

Trial Locations

Locations (1)

Christopher PAYAN; 🇫🇷 Brest, France