MucoviscidosisNCT03653377
Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)
An observational study of Mucoviscidosis, run by Hospices Civils de Lyon at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years, women only
- Conditions the study is for
- Mucoviscidosis
- What is being tested?
- Self administrated questionnaire
- How many people
- 81 participants
- Where
- 7 sitesFrance
- Study dates
- 17 Dec 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Cohort of minor girls with cystic fibrosis older than 9 years, followed in a pediatric Mucoviscidosis Resource and Competence Center (MRCC).
Who may be able to join
- 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
Who cannot join
- -patients who refuse to answer to the self-administrated questionnaire
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Service Mucoviscidose, Pneumologie
Bron
Hôpital d'Estaing
Clermont-Ferrand
Pôle Couple / Enfant
Grenoble
CRCM, Hôpital Robert Debré
Paris
CRCM, Hôpital Trousseau
Paris
CRCM, Institut Necker Enfants Malade
Paris
Centre de Ressources et de Compétences de la Mucoviscidose Adultes
Pierre-Bénite
About this study
Official title: Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France
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.
Read more
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.
- Conditions
- Mucoviscidosis
- Being tested
- Self administrated questionnaire
- Keywords
- mucoviscidosis, Human Papilloma Virus, Vaccination, Young girl
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self administrated questionnaireOther
Questionnaires are distributed to patients with their parents during their visit to the CF center.
| Study group | Role | What they receive |
|---|---|---|
| Patients with self-administered questionnaire | Not described Receives: Other: Self administrated questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start17 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucoviscidosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine ROUSSET-JABLONSKI, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653377
- Sponsor's protocol ID
- 69HCL18_0144
- Other IDs
- 2018-A01314-51
- Status last verified
- Jun 2021
- First submitted
- 29 Aug 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France
- ClinicalTrials.gov ID
- NCT03653377
- Acronym / sponsor ID
- 69HCL18_0144
- Conditions
- Mucoviscidosis
- Keywords
- mucoviscidosis, Human Papilloma Virus, Vaccination, Young girl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with self-administered questionnaire | – | Other: Self administrated questionnaire |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cohort of minor girls with cystic fibrosis older than 9 years, followed in a pediatric Mucoviscidosis Resource and Competence Center (MRCC).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -patients who refuse to answer to the self-administrated questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self administrated questionnaireQuestionnaires are distributed to patients with their parents during their visit to the CF center. | Other | Patients with self-administered questionnaire |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine ROUSSET-JABLONSKI, MD principal investigator
Hospices Civils de Lyon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucoviscidosis, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.