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Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort " REPA ")

Sponsor
Imagine Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT06000527
Collaborator
(none)
200
Enrollment
1
Location
120
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort " REPA ")
    Actual Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2032
    Anticipated Study Completion Date :
    Sep 30, 2032

    Outcome Measures

    Primary Outcome Measures

    1. Epidemiology of juvenile RRP in France by clinical information [10 years]

      age at onset of disease, symptoms, severity score, intensity of disease characterized by need for endoscopies

    2. Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information [10 years]

      Vaccination and adjuvant therapy information

    3. Epidemiology of juvenile PRR in France by paraclinical information [10 years]

      results of pulmonary imaging, genetic, anatomopathological and immunological tests

    Secondary Outcome Measures

    1. Define standardized management of juvenile RRP [10 years]

      Correlations between disease progression and frequency of follow-up, as well as treatments implemented (therapeutic or surgical interventions)

    2. Therapeutic management of RRP [10 years]

      Frequency of therapeutic surgery Use of adjuvant therapies

    3. Prevention of RRP [10 years]

      Analysis of national vaccination coverage with a vaccine immunizing against HPV 6 and 11

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Patients objecting to the collection of their personal data

    • Parents of minor patients objecting to the collection of their child's personal data

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 hôpital Necker Enfants malades Paris France 75015

    Sponsors and Collaborators

    • Imagine Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imagine Institute
    ClinicalTrials.gov Identifier:
    NCT06000527
    Other Study ID Numbers:
    • HJ-20-REPA
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Tract Infections
    Papillomavirus Infections
    Papilloma
    Recurrence

    Study Results

    No Results Posted as of Aug 21, 2023