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

August 17, 2023 updated by: Imagine Institute
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with juvenile PRR in France

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 years
Therapeutic management of RRP
Time Frame: 10 years
  • Frequency of therapeutic surgery
  • Use of adjuvant therapies
10 years
Prevention of RRP
Time Frame: 10 years
Analysis of national vaccination coverage with a vaccine immunizing against HPV 6 and 11
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imagine Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

September 30, 2032

Study Completion (Estimated)

September 30, 2032

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJ-20-REPA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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