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NCT Number: NCT06000527

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

hôpital Necker Enfants malades

Paris, 75015, France

Location status: Recruiting

Location contact

Nicolas Leboulanger

CONTACT

[email protected]

0144494682

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas LEBOULANGER, MD

CONTACT

[email protected]

0144494682

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Registry information

Acronym: REPA

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.