An observational study in Recurrent Respiratory Papillomatosis and Human Papilloma Virus, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Status unknown at 48 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Observational
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Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition affecting all ages, but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple therapies or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which therapies or procedures work best. Aim: To identify which RRP treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment.
Method: Collect information from usual patient care and quality of life questionnaire responses in a secure online database. Participation in this study requires patient/parent/guardian consent. This observational study does not require patients to undergo any additional intervention as part of the research.
Primary aim:
The overall goal is to improve the care of patients with Recurrent Respiratory Papillomatosis (RRP) - and the investigators aim to do this by determining the most effective and safe RRP treatments currently being used in patients in National Health Service (NHS) hospitals within the United Kingdom (UK) (information which is currently lacking).
By determining the most effective treatments of RRP, the investigators will be able to increase the time interval between surgical interventions to maintain symptomatic control, reduce overall number of RRP interventions, severity and spread of papillomas in the airway, hospital visits, medications and ultimately improve quality of life in those suffering from RRP. By also capturing peri- and post-procedural details the investigators will be able to determine the relative safety of treatments and identify those which slow the progression of disease.
From the data collected the investigators intend to identify patient subgroups (based on patient characteristics such as age, gender, human papillomavirus (HPV) type, location of papillomas, RRP severity and spread, comorbidities) who respond better to specific treatments, and also identify patient risk factors which contribute to the complication outcomes (such as tracheostomy).
Secondary aims:
Objectives:
The investigators will make use of an existing secure online database platform (the Airway Intervention Registry, AIR - developed and hosted by The Newcastle upon Tyne Hospitals NHS Foundation Trust, NUTH) and its associated infrastructure and develop it to capture additional observational outcomes from standard clinical practice and quality of life questionnaires from RRP patients. All RRP patients (any age) receiving treatment in any UK NHS hospital will be eligible for inclusion. Data collection will be open for 53 months with no minimum follow-up required for patients. Due to its recurrent nature (requiring regular hospital visits to maintain an open airway), following this patient population will allow the investigators to determine both the short- and long-term relative safety and efficacy of RRP treatments used in the UK. Consent will be required (from patients/parent/guardian) before data are entered into the online database.
31 studies on the registry are indexed under Recurrent respiratory papillomatosis; 9 are open to participants now.
Browse Recurrent respiratory papillomatosis studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with respiratory papillomatosis receiving hospital treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Removal of lesions via microdebrider
Removal of lesions via forceps
Removal of lesions via carbon dioxide laser
Removal of lesions via KTP laser
Removal of lesions via pulsed dye laser
Removal of lesions via radiofrequency ablation
Removal of lesions via monopolar suction diathermy
Removal of lesions via plasma coagulation
Removal of lesions via other methods
All adjuvant therapies
Also known as: Acyclovir, Artemisinin, Bevacizumab (Avastin), Celecoxib (Celebrex), Cidofovir, Cimetidine, Di-indolmethane (DIM), Gardasil, Indole-3-carbinol (I3C), alpha-Interferon, PEG-Interferon, Methotrexate, Retinoic acid (isotretinoin), Ribavarin, Other
Time interval between surgical interventions
Time between surgical interventions to maintain symptomatic control
Time frame: Over study duration (53 months)
RRP surgical intervention - nature
Nature of intervention
Time frame: Over study duration (53 months)
RRP surgical intervention - timing
Timing of intervention
Time frame: Over study duration (53 months)
RRP adjuvant therapy - nature
Nature of intervention
Time frame: Over study duration (53 months)
RRP adjuvant therapy - timing
Timing of intervention
Time frame: Over study duration (53 months)
Histology results
Including HPV type
Time frame: Over study duration (53 months)
Severity of papillomas
Measured via Derkay severity score (higher score corresponding with higher severity; clinical score range 0-11, anatomical score range 0-75, summed total score range 0-86)
Time frame: Over study duration (53 months)
Number of hospital visits/attendances
Inpatient, Accident \& emergency, Outpatient
Time frame: Over study duration (53 months)
Voice assessment (paediatric)
Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)
Time frame: Over study duration (53 months)
Voice assessment (adult)
Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)
Time frame: Over study duration (53 months)
Short-term complications
Complications arising in-hospital
Time frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
Post-operative discharge location - planned
Planned discharge location (decided pre-operation)
Time frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
Post-operative discharge location - actual
Actual discharge location (occurring post-operation)
Time frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
Long-term complications
Unexpected hospital, Accident \& emergency (A\&E), General Practitioner (GP) attendances due to RRP symptoms.
Time frame: Over study duration (53 months)
Impact of COVID
Test results, antibody results, symptoms, changes to management,
Time frame: From March 2020 onwards (30 months)
Plan to share: No — Patients will be informed that all data collected will be used for research purposes, no patient identifiable information will be shared with external parties for commercial purposes, patient identifiable information will only be accessible by clinicians at their treating organisation, pseudonymised data will be accessed by study analysts, and that only anonymised high-level aggregate data will be shared with other centres to update participating centres of study progress and data completeness issues. Patients will also be informed that any external researchers requesting data from the registry will be required to submit a formal application form and evidence of appropriate ethical approvals in place for review by the Steering Group. If approval is given, only anonymised data will be shared for the purposes of external research studies.
No publications or documents are linked to this record.
Started Apr 2018 (actual). Primary completion is estimated for Aug 2022, 52 months after the start.
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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Recurrent respiratory papillomatosis →
Newcastle-upon-Tyne Hospitals NHS Trust