Urinary Human Papilloma Virus Test in the General Population in Brittany

NCT ID: NCT03598946

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2023-10-29

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.

Conditions

Neoplasms,Ovarian

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Human Papilloma Virus Test urinary

Urinary Test by a kit which is send to the woman's house

Group Type: EXPERIMENTAL

Urinary test

Intervention Type: DEVICE

Women use a home urinary test themselves

Interventions

Urinary test

Women use a home urinary test themselves

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Association for the Screening of Cancers in Finistère

OTHER

Sponsor Role: collaborator

ADECI35

UNKNOWN

Sponsor Role: collaborator

ADECARMOR

UNKNOWN

Sponsor Role: collaborator

ADECAM INDUSTRIE

OTHER

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Christopher PAYAN

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christopher PAYAN, PUPH

Role: CONTACT

christopher.payan@chu-brest.fr

298145101 ext. +33

Facility Contacts

Christropher Payan

Role: primary

Other Identifiers

29BRC18.0092_PapU-Access

Identifier Type: -

Identifier Source: org_study_id