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临床试验/NCT03653377
NCT03653377已完成不适用

Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France

Hospices Civils de Lyon7 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2018年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
7
主要终点
HPV vaccination

研究概览

简要总结

Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.

Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

The secondary objectives are to know:

  • The type of vaccine used (bivalent / quadrivalent / nonavalent)
  • The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
  • Reasons for non-use of vaccination

Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.

Population

  • young girls aged 9 years or older with Cystic fibrosis
  • Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
  • With parents who did not object to participation in the study

Number of subject: 62 patients

Expected results

  • Knowledge of HPV vaccination coverage in young girls with CF.
  • Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • young girls aged 9 years or older
  • patients with Cystic Fibrosis
  • patients followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
  • patients with parents who did not object to participation in the study

排除标准

  • patients who refuse to answer to the self-administrated questionnaire

结局指标

主要结局

HPV vaccination

时间窗: Baseline

The outcome measure is having HPV vaccination. This information is collected through a self-questionnaire, completed by the patients or their parents, during a visit to the CF center

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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