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Clinical Trials/NCT03653377
NCT03653377
Completed
Not Applicable

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

Hospices Civils de Lyon7 sites in 1 country81 target enrollmentDecember 17, 2018
ConditionsMucoviscidosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mucoviscidosis
Sponsor
Hospices Civils de Lyon
Enrollment
81
Locations
7
Primary Endpoint
HPV vaccination
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
December 17, 2018
End Date
April 30, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

HPV vaccination

Time Frame: 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

Study Sites (7)

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