Clinical trial NCT03598946: Urinary Human Papilloma Virus Test in the General Population in Brittany
Official title: Evaluation of the Impact of a Screening Strategy Based on a Home Urinary Test in Non-respondent Women on a First Invitation to Papillomavirus Screening, on the Participation Rate Compared to a Uterine Cervix Smear Screening, With Taking Into Account the Socio-economic Level, During the Organized Screening for Cervical Cancer in Brittany
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms,Ovarian
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Association for the Screening of Cancers in Finistère
name: ADECI35
name: ADECARMOR
name: ADECAM INDUSTRIE
First posted: 2018-07-26
Enrollment: 12500
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Rate of participation in the urinary group
timeFrame: 18 months
Secondary outcomes:
measure: Participation rate by different parameters
timeFrame: 18 months
measure: Evaluation of access of the medical network with different indicators
timeFrame: 18 months
measure: Evaluation of the Papillomavirus levels of genotype 16 and genotype 18 in the population
timeFrame: 18 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Christopher PAYAN
Study officials:
References: