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Urinary Human Papilloma Virus Test in the General Population in Brittany

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03598946
Acronym
PapU-Access
Enrollment
1809
Registered
2018-07-26
Start date
2021-04-29
Completion date
2022-11-03
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms,Ovarian

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.

Interventions

Women use a home urinary test themselves

Sponsors

University Hospital, Brest
Lead SponsorOTHER
Association for the Screening of Cancers in Finistère
CollaboratorOTHER
ADECI35
CollaboratorUNKNOWN
ADECARMOR
CollaboratorUNKNOWN
ADECAM INDUSTRIE
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of participation in the urinary group18 monthsTo evaluate the rate of participation in the urinary test group

Secondary

MeasureTime frameDescription
Participation rate by different parameters18 monthsTo evaluate the participation rate
Evaluation of access of the medical network with different indicators18 monthsTo evaluate the access to the medical network
Evaluation of the Papillomavirus levels of genotype 16 and genotype 18 in the population18 monthsTo evaluate the Papillomavirus levels of genotype 16 and genotype 18

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026