Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)

Human Papilloma Virus Clinical Trial

— AIR:RRP  

Official title:

Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465280
• Other study ID #: 08733
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2022
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: Andrew Sims
• Phone: 0191 244 8738
• Email: nuth.NMPCE.Air[@]nhs.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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:

• build an evidence base of the different RRP treatments used across the UK which will help to formulate hypotheses for future research in RRP and improve quality of life for RRP patients;

• inform National Institute for Health and Care Excellence (NICE) interventional procedure guidance on radiofrequency cold ablation (IPG434,2012), which is currently under special arrangements due to lack of safety and efficacy evidence;

• identify common symptoms or signs associated with RRP disease profile, to aid future diagnosis of RRP;

• determine the geographical spread of RRP patients across the UK, to inform effective use of future NHS resources and inform the Department of Health strategy in its quadrivalent HPV vaccination programme (protecting against four types of HPV including types 6 and 11 commonly associated with RRP) currently offered to 12-13 year old girls within the NHS childhood vaccination programme;

• inform future development of national clinical guidance on management of RRP to ensure that everyone receives the best care based on best available current knowledge;

• determine impact of COVID on RRP patients including changes to RRP management, RRP symptoms.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients of any age (no restrictions) diagnosed with (newly diagnosed or existing) and receiving treatment for respiratory papillomatosis

• informed assent/consent of data participation provided by patient/parent/guardian

Exclusion Criteria:

• patients participating in other studies

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma
• Papillomavirus Infections
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Intervention

Procedure:
• Microdebrider
Removal of lesions via microdebrider
• Cold-steel surgery (forceps)
Removal of lesions via forceps
• Carbon dioxide laser
Removal of lesions via carbon dioxide laser
• Potassium titanyl phosphate (KTP) laser
Removal of lesions via KTP laser
• Pulsed dye laser
Removal of lesions via pulsed dye laser
• Radiofrequency ablation
Removal of lesions via radiofrequency ablation
• Monopolar suction diathermy
Removal of lesions via monopolar suction diathermy
• Plasma coagulation
Removal of lesions via plasma coagulation
• Other
Removal of lesions via other methods

Other:
• Adjuvant therapies
All adjuvant therapies

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen
United Kingdom	Betsi Cadwaladr University Health Board,	Bangor
United Kingdom	Basildon & Thurrock University Hospitals NHS FT	Basildon
United Kingdom	Belfast Health and Social Care Trust	Belfast
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Blackpool Teaching Hospital NHS FT	Blackpool
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Cardiff and Vale University Local Health Board	Cardiff
United Kingdom	North Cumbria Univeristy Hospital NHS Trust	Carlisle
United Kingdom	Hywel Dda University Health Board	Carmarthen
United Kingdom	County Durham and Darlington NHS Foundation Trust	Darlington
United Kingdom	University Hospitals of Derby and Burton NHS Foundation Trust	Derby
United Kingdom	Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust	Doncaster
United Kingdom	NHS Tayside	Dundee
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	Frimley Health NHS Foundation Trust	Frimley
United Kingdom	NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	London North West University Healthcare NHS Trust	Harrow
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Alder Hey Children's NHS Foundation Trust	Liverpool
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Great Ormond Street Hospital for Children NHS FT	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Lewisham and Greenwich NHS Trust	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Bedfordshire Hospitals NHS Foundation Trust	Luton
United Kingdom	Manchester University Hospital NHS Foundation Trust	Manchester
United Kingdom	Pennine Acute Hospitals NHS Trust	Manchester
United Kingdom	South Tees Hospitals NHS Foundation Trust	Middlesbrough
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	Isle of Wight NHS Trust	Newport
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	University Hospital of Plymouth NHS Trust	Plymouth
United Kingdom	Swansea Bay University Health Board	Port Talbot
United Kingdom	East Sussex Healthcare NHS Trust	Saint Leonards-on-Sea
United Kingdom	Salford Royal NHS Foundation Trust	Salford
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield
United Kingdom	The Shrewsbury and Telford Hospital NHS Trust	Shrewsbury
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	Stockport NHS Foundation Trust	Stockport
United Kingdom	South Tyneside and Sunderland NHS Foundation Trust	Sunderland
United Kingdom	Wirral University Teaching Hospitals NHS Foundation Trust	Wirral

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Alder Hey Children's NHS Foundation Trust, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time interval between surgical interventions	Time between surgical interventions to maintain symptomatic control	Over study duration (53 months)
Secondary	RRP surgical intervention - nature	Nature of intervention	Over study duration (53 months)
Secondary	RRP surgical intervention - timing	Timing of intervention	Over study duration (53 months)
Secondary	RRP adjuvant therapy - nature	Nature of intervention	Over study duration (53 months)
Secondary	RRP adjuvant therapy - timing	Timing of intervention	Over study duration (53 months)
Secondary	Histology results	Including HPV type	Over study duration (53 months)
Secondary	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)	Over study duration (53 months)
Secondary	Number of hospital visits/attendances	Inpatient, Accident & emergency, Outpatient	Over study duration (53 months)
Secondary	Voice assessment (paediatric)	Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)	Over study duration (53 months)
Secondary	Voice assessment (adult)	Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)	Over study duration (53 months)
Secondary	Short-term complications	Complications arising in-hospital	During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
Secondary	Post-operative discharge location - planned	Planned discharge location (decided pre-operation)	During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
Secondary	Post-operative discharge location - actual	Actual discharge location (occurring post-operation)	During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
Secondary	Long-term complications	Unexpected hospital, Accident & emergency (A&E), General Practitioner (GP) attendances due to RRP symptoms.	Over study duration (53 months)
Secondary	Impact of COVID	Test results, antibody results, symptoms, changes to management,	From March 2020 onwards (30 months)