Clinical trial NCT03465280: Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)
Official title: Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Respiratory Papillomatosis
Human Papilloma Virus
Keywords: Recurrent respiratory papillomatosis
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Alder Hey Children's NHS Foundation Trust
name: National Institute for Health Research, United Kingdom
First posted: 2018-03-14
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with respiratory papillomatosis receiving hospital treatment

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time interval between surgical interventions
timeFrame: Over study duration (53 months)
Secondary outcomes:
measure: RRP surgical intervention - nature
timeFrame: Over study duration (53 months)
measure: RRP surgical intervention - timing
timeFrame: Over study duration (53 months)
measure: RRP adjuvant therapy - nature
timeFrame: Over study duration (53 months)
measure: RRP adjuvant therapy - timing
timeFrame: Over study duration (53 months)
measure: Histology results
timeFrame: Over study duration (53 months)
measure: Severity of papillomas
timeFrame: Over study duration (53 months)
measure: Number of hospital visits/attendances
timeFrame: Over study duration (53 months)
measure: Voice assessment (paediatric)
timeFrame: Over study duration (53 months)
measure: Voice assessment (adult)
timeFrame: Over study duration (53 months)
measure: Short-term complications
timeFrame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
measure: Post-operative discharge location - planned
timeFrame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
measure: Post-operative discharge location - actual
timeFrame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)
measure: Long-term complications
timeFrame: Over study duration (53 months)
measure: Impact of COVID
timeFrame: From March 2020 onwards (30 months)
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Bangor
country: United Kingdom
facility: Betsi Cadwaladr University Health Board,
city: Basildon
country: United Kingdom
facility: Basildon & Thurrock University Hospitals NHS FT
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's NHS Foundation Trust
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospital NHS FT
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Local Health Board
city: Carlisle
country: United Kingdom
facility: North Cumbria Univeristy Hospital NHS Trust
city: Carmarthen
country: United Kingdom
facility: Hywel Dda University Health Board
city: Darlington
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Frimley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Lewisham and Greenwich NHS Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS FT
city: Luton
country: United Kingdom
facility: Bedfordshire Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Newport
country: United Kingdom
facility: Isle of Wight NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: University Hospital of Plymouth NHS Trust
city: Port Talbot
country: United Kingdom
facility: Swansea Bay University Health Board
city: Saint Leonards-on-Sea
country: United Kingdom
facility: East Sussex Healthcare NHS Trust
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
city: Shrewsbury
country: United Kingdom
facility: The Shrewsbury and Telford Hospital NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Stockport
country: United Kingdom
facility: Stockport NHS Foundation Trust
city: Sunderland
country: United Kingdom
facility: South Tyneside and Sunderland NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: Wirral University Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Alder Hey Children's NHS Foundation Trust
name: Adam Donne
role: PRINCIPAL_INVESTIGATOR
References: