Urinary Human Papilloma Virus Test in the General Population in Brittany (PapU-Access)
Primary Purpose
Neoplasms,Ovarian
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urinary test
Sponsored by
About this trial
This is an interventional prevention trial for Neoplasms,Ovarian
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
Sites / Locations
- Christopher PAYANRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Human Papilloma Virus Test urinary
Arm Description
Urinary Test by a kit which is send to the woman's house
Outcomes
Primary Outcome Measures
Rate of participation in the urinary group
To evaluate the rate of participation in the urinary test group
Secondary Outcome Measures
Participation rate by different parameters
To evaluate the participation rate
Evaluation of access of the medical network with different indicators
To evaluate the access to the medical network
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
Full Information
NCT ID
NCT03598946
First Posted
July 16, 2018
Last Updated
July 13, 2022
Sponsor
University Hospital, Brest
Collaborators
Association for the Screening of Cancers in Finistère, ADECI35, ADECARMOR, ADECAM INDUSTRIE
1. Study Identification
Unique Protocol Identification Number
NCT03598946
Brief Title
Urinary Human Papilloma Virus Test in the General Population in Brittany
Acronym
PapU-Access
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
October 29, 2022 (Anticipated)
Study Completion Date
October 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Association for the Screening of Cancers in Finistère, ADECI35, ADECARMOR, ADECAM INDUSTRIE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
D0-M6: Pre-inclusion phase with implementation of the protocol (regulatory procedures, production of newsletters, consent, questionnaire, preparation of urine collection kits, postal validation).
M6-M18: Inclusion phase with start of the study, sending invitations and inclusion, Human Papillomavirus Urinary testing and uterine cervix smear monitoring.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms,Ovarian
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Human Papilloma Virus Test urinary
Arm Type
Experimental
Arm Description
Urinary Test by a kit which is send to the woman's house
Intervention Type
Device
Intervention Name(s)
Urinary test
Intervention Description
Women use a home urinary test themselves
Primary Outcome Measure Information:
Title
Rate of participation in the urinary group
Description
To evaluate the rate of participation in the urinary test group
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Participation rate by different parameters
Description
To evaluate the participation rate
Time Frame
18 months
Title
Evaluation of access of the medical network with different indicators
Description
To evaluate the access to the medical network
Time Frame
18 months
Title
Evaluation of the Papillomavirus levels of genotype 16 and genotype 18 in the population
Description
To evaluate the Papillomavirus levels of genotype 16 and genotype 18
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher PAYAN, PUPH
Phone
298145101
Ext
+33
Email
christopher.payan@chu-brest.fr
Facility Information:
Facility Name
Christopher PAYAN
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christropher Payan
First Name & Middle Initial & Last Name & Degree
Christopher Payan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Urinary Human Papilloma Virus Test in the General Population in Brittany
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