Urinary Human Papilloma Virus Test in the General Population in Brittany (PapU-Access)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms,Ovarian
• Intervention / Treatment: Device: Urinary test

• Study Type: Interventional
• Enrollment (Anticipated): 12500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher PAYAN, PUPH; Phone Number: +33 298145101; Email: christopher.payan@chu-brest.fr

Study Locations

• France
  • Brest, France
    • Recruiting
    • Christopher PAYAN
    • Contact: Christropher Payan
    • Principal Investigator: Christopher Payan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Papilloma Virus Test urinary; Urinary Test by a kit which is send to the woman's house	Device: Urinary test; Women use a home urinary test themselves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of participation in the urinary group	To evaluate the rate of participation in the urinary test group	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Association for the Screening of Cancers in Finistère; ADECI35; ADECARMOR; ADECAM INDUSTRIE

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Anticipated): October 29, 2022
• Study Completion (Anticipated): October 29, 2023

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: 29BRC18.0092_PapU-Access

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No