Urinary Human Papilloma Virus Test in the General Population in Brittany

NCT03598946 | Unknown DMC

• 1 other identifier: 29BRC18.0092_PapU-Access
• Study Type: interventional
• Target: 12,500
• Locations: 1 country
• Sites: 1

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. 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. 2.M6-M18: Inclusion phase with start of the study, sending invitations and inclusion, Human Papillomavirus Urinary testing and uterine cervix smear monitoring.
3. 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.

Conditions

Neoplasms,Ovarian

Outcome Measures

Primary Outcomes (1)

• Rate of participation in the urinary group

  To evaluate the rate of participation in the urinary test group

  18 months

Secondary Outcomes (3)

• Participation rate by different parameters

  18 months

• Evaluation of access of the medical network with different indicators

  18 months

• Evaluation of the Papillomavirus levels of genotype 16 and genotype 18 in the population

  18 months

Study Arms (1)

Human Papilloma Virus Test urinary

EXPERIMENTAL

Urinary Test by a kit which is send to the woman's house

Device: Urinary test

Interventions

Urinary test DEVICE

Women use a home urinary test themselves

Human Papilloma Virus Test urinary

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women from 30 to 65 years old who did not do uterine cervix smear and who live in Brittany

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• Association for the Screening of Cancers in Finistère: collaborator
• ADECI35: collaborator
• ADECARMOR: collaborator
• ADECAM INDUSTRIE: collaborator

Study Sites (1)

Christopher PAYAN

Brest, France

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Antibody-Coated Bacteria Test, Urinary

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Fluorescent Antibody Technique; Immunohistochemistry; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Tests; Diagnostic Techniques, Urological; Investigative Techniques; Immunologic Techniques

Central Study Contacts

Christopher PAYAN, PUPH

CONTACT

298145101; christopher.payan@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: April 29, 2021
• Primary Completion: October 29, 2022
• Study Completion: October 29, 2023
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)