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Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653377
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Mucoviscidosis Other: Self administrated questionnaire

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Patients with self-administered questionnaire Other: Self administrated questionnaire
Questionnaires are distributed to patients with their parents during their visit to the CF center.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of minor girls with cystic fibrosis older than 9 years, followed in a pediatric Mucoviscidosis Resource and Competence Center (MRCC).
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


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): NCT03653377


Contacts
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Contact: Christine ROUSSET-JABLONSKI, MD 04.78.56.90.49 ext +33 christine.rousset-jablonski@chu-lyon.fr
Contact: Sandrine TOUZET, MD 04 72 11 57 61 ext +33 sandrine.touzet@chu-lyon.fr

Locations
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France
Service Mucoviscidose, Pneumologie
Bron, France
Contact: Philippe REIX, MP    04.27.85.54.70 ext +33    philippe.reix@chu.lyon.fr   
Principal Investigator: Philippe REIX         
Hôpital d'Estaing
Clermont-Ferrand, France
Contact: André LABBE, MP    04 73 75 06 11 ext +33    alabbe@chu-clermontferrand.fr   
Principal Investigator: André LABBE, MP         
Pôle Couple / Enfant
Grenoble, France
Contact: Isabelle PIN, MD    04 76 76 51 89 ext +33    ipin@chu-grenoble.fr   
Principal Investigator: Isabelle PIN, MD         
CRCM, Hôpital Robert Debré
Paris, France
Contact: Michèle Gerardin, MD    01 40 03 47 54 ext +33    michele.gerardin@aphp.fr   
Principal Investigator: Michèle Gerardin, MD         
CRCM, Hôpital Trousseau
Paris, France
Contact: Harriet Corvol, MP    01 44 73 68 77 ext +33    harriet.corvol@aphp.fr   
Principal Investigator: Harriet Corvol, MP         
CRCM, Institut Necker Enfants Malade
Paris, France
Contact: Isabelle Sermet-Gaudelus, MP    01 44 49 48 87 ext +33    isabelle.sermet@aphp.fr   
Principal Investigator: Isabelle Sermet-Gaudelus, MP         
Centre de Ressources et de Compétences de la Mucoviscidose Adultes
Pierre-Bénite, France
Contact: Christine ROUSSET-JABLONSKI, MD    04.78.56.90.49 ext +33    christine.rousset-jablonski@chu-lyon.fr   
Contact: Sandrine TOUZET, MD    04 72 11 57 61 ext +33    sandrine.touzet@chu-lyon.fr   
Principal Investigator: Christine ROUSSET-JABLONSKI, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Christine ROUSSET-JABLONSKI, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03653377    
Other Study ID Numbers: 69HCL18_0144
2018-A01314-51 ( Other Identifier: ID-RCB )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
mucoviscidosis
Human Papilloma Virus
Vaccination
Young girl
Additional relevant MeSH terms:
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Papilloma
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs