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临床试验/NCT03598946
NCT03598946终止不适用

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

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 1,809 人开始时间: 2021年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1,809
试验地点
2
主要终点
Rate of participation in the urinary group

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Human Papilloma Virus Test urinary

Experimental

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

干预措施: Urinary test (Device)

结局指标

主要结局

Rate of participation in the urinary group

时间窗: 18 months

To evaluate the rate of participation in the urinary test group

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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