Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)
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|ClinicalTrials.gov Identifier: NCT03653377|
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
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.
- 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
- 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.
|Condition or disease||Intervention/treatment|
|Mucoviscidosis||Other: Self administrated questionnaire|
|Study Type :||Observational|
|Estimated Enrollment :||62 participants|
|Official Title:||Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||October 2019|
|Patients with self-administered questionnaire||
Other: Self administrated questionnaire
Questionnaires are distributed to patients with their parents during their visit to the CF center.
- 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
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): NCT03653377
|Contact: Christine ROUSSET-JABLONSKI, MD||04.78.56.90.49 ext +email@example.com|
|Contact: Sandrine TOUZET, MD||04 72 11 57 61 ext +firstname.lastname@example.org|
|Service Mucoviscidose, Pneumologie|
|Contact: Philippe REIX, MP 04.27.85.54.70 ext +33 email@example.com|
|Principal Investigator: Philippe REIX|
|Contact: André LABBE, MP 04 73 75 06 11 ext +33 firstname.lastname@example.org|
|Principal Investigator: André LABBE, MP|
|Pôle Couple / Enfant|
|Contact: Isabelle PIN, MD 04 76 76 51 89 ext +33 email@example.com|
|Principal Investigator: Isabelle PIN, MD|
|CRCM, Hôpital Robert Debré|
|Contact: Michèle Gerardin, MD 01 40 03 47 54 ext +33 firstname.lastname@example.org|
|Principal Investigator: Michèle Gerardin, MD|
|CRCM, Hôpital Trousseau|
|Contact: Harriet Corvol, MP 01 44 73 68 77 ext +33 email@example.com|
|Principal Investigator: Harriet Corvol, MP|
|CRCM, Institut Necker Enfants Malade|
|Contact: Isabelle Sermet-Gaudelus, MP 01 44 49 48 87 ext +33 firstname.lastname@example.org|
|Principal Investigator: Isabelle Sermet-Gaudelus, MP|
|Centre de Ressources et de Compétences de la Mucoviscidose Adultes|
|Contact: Christine ROUSSET-JABLONSKI, MD 04.78.56.90.49 ext +33 email@example.com|
|Contact: Sandrine TOUZET, MD 04 72 11 57 61 ext +33 firstname.lastname@example.org|
|Principal Investigator: Christine ROUSSET-JABLONSKI, MD|
|Principal Investigator:||Christine ROUSSET-JABLONSKI, MD||Hospices Civils de Lyon|