Urinary Human Papilloma Virus Test in the General Population in Brittany

  • STATUS
    Recruiting
  • End date
    Apr 29, 2023
  • participants needed
    12500
  • sponsor
    University Hospital, Brest
Updated on 13 May 2021

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.

Details
Condition Ovarian Cancer, Recurrent Ovarian Cancer
Treatment Urinary test
Clinical Study IdentifierNCT03598946
SponsorUniversity Hospital, Brest
Last Modified on13 May 2021

Eligibility

Yes No Not Sure

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
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