Human Papillomavirus InfectionVACCIN-HPV-MUCNCT03265743
HPV Vaccination in Women With Cystic Fibrosis
An observational study of Human Papillomavirus Infection, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years, women only
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Self-report Written Questionnaire
- How many people
- 74 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Sep 2017to 15 Dec 2017
- 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 11 to 18 years
- Women only
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Refusal to respond to the questionnaire
Trial locations and contacts
3 sites in 1 country.
France3 sites
Nouvel Hôpital d'Estaing CRCM Mixte
Clermont-Ferrand, 63003
CHU Grenoble
Grenoble, 38043
Cystic Fibrosis Reference Center, Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Official title: HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region
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.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Self-report Written Questionnaire
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-report Written QuestionnaireOther
Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-report Written Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Realization of human papillomavirus vaccination
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
Measured: 15 minutes
Secondary outcomes (3)
Type of vaccine used
This data is collected using a questionnaire : bivalent (Cervarix®) or quadrivalent (Gardasil®)
Measured: 15 minutes
Respect for the vaccinal plan
This data is collected using a questionnaire : number and dates of injections
Measured: 15 minutes
Reasons for non-vaccination
In case of non-vaccination reasons are collected using a multiple choices questionnaire
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start25 Sep 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265743
- Sponsor's protocol ID
- 69HCL17_0277
- Acronym
- VACCIN-HPV-MUC
- Status last verified
- Jul 2017
- First submitted
- 27 Jul 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region
- ClinicalTrials.gov ID
- NCT03265743
- Acronym / sponsor ID
- VACCIN-HPV-MUC / 69HCL17_0277
- Conditions
- Human Papillomavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 29 Aug 2017 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cystic Fibrosis | – | Other: Self-report Written QuestionnairePatients with Cystic Fibrosis, followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA), aged 11 years or older. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to respond to the 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-report Written QuestionnaireInformations are gathered through a self-report written questionnaire, completed by the patients or their parents. | Other | Patients with Cystic Fibrosis |
Primary outcome
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
3 secondary outcomes
Type of vaccine used
Time frame: 15 minutes
Respect for the vaccinal plan
Time frame: 15 minutes
Reasons for non-vaccination
Time frame: 15 minutes
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 19 Feb 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by Hospices Civils de Lyon at 3 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 3 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Realization of human papillomavirus vaccination (time frame: 15 minutes). 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 19 Feb 2018.