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

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ClinicalTrials.gov Identifier: NCT06000527
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Information provided by (Responsible Party):
Imagine Institute

Study Description
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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
Juvenile Recurrent Respiratory Papillomatosis

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
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Study Type : Observational
Estimated 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 : October 1, 2022
Estimated Primary Completion Date : September 30, 2032
Estimated Study Completion Date : September 30, 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information [ Time Frame: 10 years ]
    Vaccination and adjuvant therapy information

  3. Epidemiology of juvenile PRR in France by paraclinical information [ Time Frame: 10 years ]
    results of pulmonary imaging, genetic, anatomopathological and immunological tests


Secondary Outcome Measures :
  1. Define standardized management of juvenile RRP [ Time Frame: 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 [ Time Frame: 10 years ]
    • Frequency of therapeutic surgery
    • Use of adjuvant therapies

  3. Prevention of RRP [ Time Frame: 10 years ]
    Analysis of national vaccination coverage with a vaccine immunizing against HPV 6 and 11


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with juvenile PRR in France
Criteria

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
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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): NCT06000527


Contacts
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Contact: Nicolas LEBOULANGER, MD 0144494682 nicolas.leboulanger@aphp.fr

Locations
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France
hôpital Necker Enfants malades Recruiting
Paris, France, 75015
Contact: Nicolas Leboulanger    0144494682    nicolas.leboulanger@aphp.fr   
Sponsors and Collaborators
Imagine Institute
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Imagine Institute
ClinicalTrials.gov Identifier: NCT06000527    
Other Study ID Numbers: HJ-20-REPA
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Papillomavirus Infections
Papilloma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Infections
Respiratory Tract Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Genital Diseases
Urogenital Diseases