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

Recruiting

• Conditions: Juvenile Recurrent Respiratory Papillomatosis

• Registration Number: NCT06000527
• Lead Sponsor: Imagine Institute

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.

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 Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2032-09-30
• Study Completion: 2032-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiology of juvenile PRR in France by paraclinical information	10 years	results of pulmonary imaging, genetic, anatomopathological and immunological tests
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
Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information	10 years	Vaccination and adjuvant therapy information

Secondary Outcome Measures

Name	Time	Method
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)
Prevention of RRP	10 years	Analysis of national vaccination coverage with a vaccine immunizing against HPV 6 and 11
Therapeutic management of RRP	10 years	* Frequency of therapeutic surgery; * Use of adjuvant therapies

Trial Locations

Locations (1)

hôpital Necker Enfants malades; 🇫🇷 Paris, France