Juvenile Recurrent Respiratory PapillomatosisREPANCT06000527
Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort " REPA ")
An observational study of Juvenile Recurrent Respiratory Papillomatosis, run by Imagine Institute at 1 site in France.
Trial summary
Recurrent respiratory papillomatosis (RRP) is a rare disease. However, it is the most common benign laryngeal tumor in children. To date, no epidemiological data are available in France. The aim of this study is to establish the epidemiology of juvenile PPR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Juvenile Recurrent Respiratory Papillomatosis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 30 Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with juvenile PRR in France
Who may be able to join
- Patients with juvenile PRR (disease onset before age 18)
- Followed in the :
- The MALO CRMR
- One of the MALO network's CCMRs
- One of the main correspondent centers
Who cannot join
- Patients objecting to the collection of their personal data
- Parents of minor patients objecting to the collection of their child's personal data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
hôpital Necker Enfants malades
Paris, 75015
Nicolas Leboulanger, 0144494682, nicolas.leboulanger@aphp.fr
About this study
Recurrent respiratory papillomatosis (RRP) is a rare disease. However, it is the most common benign laryngeal tumor in children. To date, no epidemiological data are available in France. The aim of this study is to establish the epidemiology of juvenile PPR.
Read the detailed description
Recurrent respiratory papillomatosis (RRP) is characterized by the recurrent proliferation of multiple polypoid squamous tumors in the respiratory tract, linked to HPV infection. RRP is a rare disease. However, it is the most common benign laryngeal tumor in children.
There are currently no French national epidemiological data on this disease. The data collected by the reference centers will enable us to gain a better understanding of this pathology in terms of epidemiology, risk factors, genetic susceptibility and clinical manifestations, as well as to significantly study the efficacy of the various existing therapies and preventive measures, in order to establish a clear, standardized and optimal guideline.
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of juvenile RRP in France by clinical information
age at onset of disease, symptoms, severity score, intensity of disease characterized by need for endoscopies
Measured: 10 years
Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information
Vaccination and adjuvant therapy information
Measured: 10 years
Epidemiology of juvenile PRR in France by paraclinical information
results of pulmonary imaging, genetic, anatomopathological and immunological tests
Measured: 10 years
Secondary outcomes (3)
Define standardized management of juvenile RRP
Correlations between disease progression and frequency of follow-up, as well as treatments implemented (therapeutic or surgical interventions)
Measured: 10 years
Therapeutic management of RRP
- Frequency of therapeutic surgery
- Use of adjuvant therapies
Measured: 10 years
Prevention of RRP
Analysis of national vaccination coverage with a vaccine immunizing against HPV 6 and 11
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Oct 2022
- Primary completion30 Sep 2032 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000527
- Sponsor's protocol ID
- HJ-20-REPA
- Acronym
- REPA
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort " REPA ")
- ClinicalTrials.gov ID
- NCT06000527
- Acronym / sponsor ID
- REPA / HJ-20-REPA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2032 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 21 Aug 2023 (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.
Recurrent respiratory papillomatosis (RRP) is a rare disease. However, it is the most common benign laryngeal tumor in children. To date, no epidemiological data are available in France. The aim of this study is to establish the epidemiology of juvenile PPR.
Detailed description
Recurrent respiratory papillomatosis (RRP) is characterized by the recurrent proliferation of multiple polypoid squamous tumors in the respiratory tract, linked to HPV infection. RRP is a rare disease. However, it is the most common benign laryngeal tumor in children.
There are currently no French national epidemiological data on this disease. The data collected by the reference centers will enable us to gain a better understanding of this pathology in terms of epidemiology, risk factors, genetic susceptibility and clinical manifestations, as well as to significantly study the efficacy of the various existing therapies and preventive measures, in order to establish a clear, standardized and optimal guideline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with juvenile PRR in France
Key inclusion criteria (5 listed)
- Patients with juvenile PRR (disease onset before age 18)
- Followed in the :
Key exclusion criteria (2 listed)
- Patients objecting to the collection of their personal data
- Parents of minor patients objecting to the collection of their child's personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology of juvenile RRP in France by clinical information
Time frame: 10 years
age at onset of disease, symptoms, severity score, intensity of disease characterized by need for endoscopies
Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information
Time frame: 10 years
Vaccination and adjuvant therapy information
Epidemiology of juvenile PRR in France by paraclinical information
Time frame: 10 years
results of pulmonary imaging, genetic, anatomopathological and immunological tests
3 secondary outcomes
Define standardized management of juvenile RRP
Time frame: 10 years
Therapeutic management of RRP
Time frame: 10 years
Prevention of RRP
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Recurrent Respiratory Papillomatosis, run by Imagine Institute at 1 site 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas LEBOULANGER, MD (0144494682, nicolas.leboulanger@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology of juvenile RRP in France by clinical information (time frame: 10 years). The study lists 3 primary outcomes in all. 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 21 Aug 2023.