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OpenTrials
Completed

NCT Number: NCT03265743

HPV Vaccination in Women With Cystic Fibrosis

The main risk factor for the development of cervical lesions is human papillomavirus (HPV) infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to 14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical pathology. Despite this, human papillomavirus vaccination coverage remains low in France.

Some women with cystic fibrosis might need a transplantation, which is a factor associated with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of cervical pathology would also be present in non-transplanted women with cystic fibrosis. Particular attention should therefore be paid to vaccination in this population.

The objective is to estimate the frequency of human papillomavirus vaccination in young patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.

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Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

11 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Nouvel Hôpital d'Estaing CRCM Mixte, Clermont-Ferrand, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • girls with Cystic Fibrosis
  • followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA)
  • aged 11 years or older

Exclusion criteria

  • Refusal to respond to the questionnaire

Treatment and study plan

Self-report Written Questionnaire

Other

Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.

Primary outcomes

  1. Realization of human papillomavirus vaccination

    Time frame: 15 minutes

    The main outcome is the prevalence of human papillomavirus vaccination in young women with Cystic fibrosis.

    This data is collected using a questionnaire : HPV vaccination performed : yes/no

Secondary outcomes

  1. Type of vaccine used

    Time frame: 15 minutes

    This data is collected using a questionnaire : bivalent (Cervarix®) or quadrivalent (Gardasil®)

  2. Respect for the vaccinal plan

    Time frame: 15 minutes

    This data is collected using a questionnaire : number and dates of injections

  3. Reasons for non-vaccination

    Time frame: 15 minutes

    In case of non-vaccination reasons are collected using a multiple choices questionnaire

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region

Acronym: VACCIN-HPV-MUC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2017
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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