VACCIN-HPV-MUC: HPV Vaccination in Women With Cystic Fibrosis

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03265743

Collaborator

(none)

Enrollment

Locations

2.7

Actual Duration (Months)

24.7

Patients Per Site

9.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Human Papillomavirus Infection	Other: Self-report Written Questionnaire

Study Design

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 :

Sep 25, 2017

Actual Primary Completion Date :

Dec 15, 2017

Actual Study Completion Date :

Dec 15, 2017

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Realization of human papillomavirus vaccination [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

Type of vaccine used [15 minutes]
This data is collected using a questionnaire : bivalent (Cervarix®) or quadrivalent (Gardasil®)
Respect for the vaccinal plan [15 minutes]
This data is collected using a questionnaire : number and dates of injections
Reasons for non-vaccination [15 minutes]
In case of non-vaccination reasons are collected using a multiple choices questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 18 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Nouvel Hôpital d'Estaing CRCM Mixte	Clermont-Ferrand	France	63003
2	CHU Grenoble	Grenoble	France	38043
3	Cystic Fibrosis Reference Center, Hospices Civils de Lyon	Pierre-Bénite	France	69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03265743

Other Study ID Numbers:

69HCL17_0277

First Posted:

Aug 29, 2017

Last Update Posted:

Feb 19, 2018

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Papillomavirus Infections

Cystic Fibrosis

Study Results

No Results Posted as of Feb 19, 2018