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HPV Vaccination in Women With Cystic Fibrosis (VACCIN-HPV-MUC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03265743
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment
Human Papillomavirus Infection Other: Self-report Written Questionnaire

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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Patients with Cystic Fibrosis
Patients with Cystic Fibrosis, followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA), aged 11 years or older.
Other: Self-report Written Questionnaire
Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
This study is intended for 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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265743


Locations
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France
Nouvel Hôpital d'Estaing CRCM Mixte
Clermont-Ferrand, France, 63003
CHU Grenoble
Grenoble, France, 38043
Cystic Fibrosis Reference Center, Hospices Civils de Lyon
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03265743     History of Changes
Other Study ID Numbers: 69HCL17_0277
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Papillomavirus Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs