Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Virus Diseases

Papilloma

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

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

Urinary test

Christopher PAYAN, PUPH

Christropher Payan

Christopher Payan

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.

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

To evaluate the rate of participation in the urinary test group

To evaluate the access to the medical network

To evaluate the Papillomavirus levels of genotype 16 and genotype 18

Association for the Screening of Cancers in Finistère

ADECI35

ADECARMOR

ADECAM INDUSTRIE

University Hospital, Brest

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

No drug and no placebo will be used in this study. For the study participants, only their medical history data and vaginal auto-takings ( APV) and urinary will be collected.

vaginal auto-takings and urinary test

Christopher PAYAN, PU-PH

Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .

Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer

Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.

Estimate the research for human Papillomavirus ( HPV) in the vaginal auto-takings ( APV) and urinary ( APU) test at women from 25 to 65 years old requiring a screening.

Estimate the practicability, the organization of the screening, the follow-up of the women at the Brest Hospital and at Landerneau Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Urinary Human Papilloma Virus Test in the General Population in Brittany	NCT03598946	Neoplasms,Ovari...	Urinary test	30 Years - 65 Years	University Hospital, Brest
Urinary Human Papilloma Virus Test in the General Population in Brittany	NCT03598946	Neoplasms,Ovari...	Urinary test	30 Years - 65 Years	University Hospital, Brest
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer	NCT02137694	Research Human ...	vaginal auto-ta...	25 Years - 65 Years	University Hospital, Brest
Urinary Human Papilloma Virus Test in the General Population in Brittany	NCT03598946	Neoplasms,Ovari...	Urinary test	30 Years - 65 Years	University Hospital, Brest
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer	NCT02137694	Research Human ...	vaginal auto-ta...	25 Years - 65 Years	University Hospital, Brest
Urinary Human Papilloma Virus Test in the General Population in Brittany	NCT03598946	Neoplasms,Ovari...	Urinary test	30 Years - 65 Years	University Hospital, Brest

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