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

Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis

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.

Study Overview

• Status: Recruiting
• Conditions: Human Papilloma Virus; Recurrent Respiratory Papillomatosis
• Intervention / Treatment: Procedure: Microdebrider; Procedure: Cold-steel surgery (forceps); Procedure: Carbon dioxide laser; Procedure: Potassium titanyl phosphate (KTP) laser; Procedure: Pulsed dye laser; Procedure: Radiofrequency ablation; Procedure: Monopolar suction diathermy; Procedure: Plasma coagulation; Procedure: Other; Other: Adjuvant therapies

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Andrew Sims; Phone Number: 0191 244 8738; Email: nuth.NMPCE.Air@nhs.net

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZB
    • Recruiting
    • NHS Grampian
  • Bangor, United Kingdom, LL57 2PW
    • Recruiting
    • Betsi Cadwaladr University Health Board,
  • Basildon, United Kingdom, SS165NL
    • Recruiting
    • Basildon & Thurrock University Hospitals NHS FT
  • Belfast, United Kingdom, BT2 8BG
    • Recruiting
    • Belfast Health and Social Care Trust
  • Birmingham, United Kingdom, B15 2GW
    • Recruiting
    • University Hospital Birmingham NHS Foundation Trust
  • Birmingham, United Kingdom, B4 6NH
    • Recruiting
    • Birmingham Women's and Children's NHS Foundation Trust
  • Blackpool, United Kingdom, FY38NR
    • Recruiting
    • Blackpool Teaching Hospital NHS FT
  • Bradford, United Kingdom, BD9 6RJ
    • Recruiting
    • Bradford Teaching Hospitals NHS Foundation Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Cambridge University Hospitals NHS Foundation Trust
  • Cardiff, United Kingdom, CF14 4XW
    • Recruiting
    • Cardiff and Vale University Local Health Board
  • Carlisle, United Kingdom, CA27HY
    • Recruiting
    • North Cumbria Univeristy Hospital NHS Trust
  • Carmarthen, United Kingdom, SA31 3BB
    • Recruiting
    • Hywel Dda University Health Board
  • Darlington, United Kingdom, DL36HX
    • Recruiting
    • County Durham and Darlington NHS Foundation Trust
  • Derby, United Kingdom, DE223NE
    • Recruiting
    • University Hospitals of Derby and Burton NHS Foundation Trust
  • Doncaster, United Kingdom, DN2 5LT
    • Recruiting
    • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • Dundee, United Kingdom, DD2 1GZ
    • Recruiting
    • NHS Tayside
  • Edinburgh, United Kingdom, EH16 4TJ
    • Recruiting
    • NHS Lothian
  • Frimley, United Kingdom, GU16 7UJ
    • Recruiting
    • Frimley Health NHS Foundation Trust
  • Glasgow, United Kingdom, G120XH
    • Recruiting
    • NHS Greater Glasgow & Clyde
  • Harrow, United Kingdom, HA1 3UJ
    • Recruiting
    • London North West University Healthcare NHS Trust
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • Leeds Teaching Hospitals NHS Trust
  • Liverpool, United Kingdom, L12 2AP
    • Recruiting
    • Alder Hey Children's NHS Foundation Trust
  • Liverpool, United Kingdom, L7 8XP
    • Recruiting
    • Liverpool University Hospitals NHS Foundation Trust
  • London, United Kingdom, W2 1NY
    • Recruiting
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College London Hospitals NHS Foundation Trust
  • London, United Kingdom, E1 2ES
    • Recruiting
    • Barts Health NHS Trust
  • London, United Kingdom, SW17 0QT
    • Recruiting
    • St George's University Hospitals NHS Foundation Trust
  • London, United Kingdom, SE13 6LH
    • Recruiting
    • Lewisham and Greenwich NHS Trust
  • London, United Kingdom, WC1N3JH
    • Recruiting
    • Great Ormond Street Hospital for Children NHS FT
  • Luton, United Kingdom, LU4 0DZ
    • Recruiting
    • Bedfordshire Hospitals Nhs Foundation Trust
  • Manchester, United Kingdom, M13 9WL
    • Recruiting
    • Manchester University Hospital NHS Foundation Trust
  • Manchester, United Kingdom, M8 5RB
    • Recruiting
    • Pennine Acute Hospitals NHS Trust
  • Middlesbrough, United Kingdom, TS4 3BW
    • Recruiting
    • South Tees Hospitals NHS Foundation Trust
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    • Contact: Andrew Sims; Email: nuth.NMPCE.Air@nhs.net
  • Newport, United Kingdom, PO30 5TG
    • Recruiting
    • Isle of Wight NHS Trust
  • Nottingham, United Kingdom, NG51PB
    • Recruiting
    • Nottingham University Hospitals NHS Trust
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • Oxford University Hospitals NHS Foundation Trust
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • University Hospital of Plymouth NHS Trust
  • Port Talbot, United Kingdom, SA12 7BR
    • Recruiting
    • Swansea Bay University Health Board
  • Saint Leonards-on-Sea, United Kingdom, TN37 7PT
    • Recruiting
    • East Sussex Healthcare Nhs Trust
  • Salford, United Kingdom, M6 8HD
    • Recruiting
    • Salford Royal NHS Foundation Trust
  • Sheffield, United Kingdom, S10 2TH
    • Recruiting
    • Sheffield Children's NHS Foundation Trust
  • Shrewsbury, United Kingdom, SY3 8XQ
    • Recruiting
    • The Shrewsbury and Telford Hospital NHS Trust
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • University Hospital Southampton NHS Foundation Trust
  • Stockport, United Kingdom, SK2 7JE
    • Recruiting
    • Stockport NHS Foundation Trust
  • Sunderland, United Kingdom, SR4 7TP
    • Recruiting
    • South Tyneside and Sunderland NHS Foundation Trust
  • Wirral, United Kingdom, CH49 5PE
    • Recruiting
    • Wirral University Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with respiratory papillomatosis receiving hospital treatment

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time interval between surgical interventions	Time between surgical interventions to maintain symptomatic control	Over study duration (53 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RRP surgical intervention - nature	Nature of intervention	Over study duration (53 months)
RRP surgical intervention - timing	Timing of intervention	Over study duration (53 months)
RRP adjuvant therapy - nature	Nature of intervention	Over study duration (53 months)
RRP adjuvant therapy - timing	Timing of intervention	Over study duration (53 months)
Histology results	Including HPV type	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)	Over study duration (53 months)
Number of hospital visits/attendances	Inpatient, Accident & emergency, Outpatient	Over study duration (53 months)
Voice assessment (paediatric)	Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)	Over study duration (53 months)
Voice assessment (adult)	Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)	Over study duration (53 months)
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)
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)
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)
Long-term complications	Unexpected hospital, Accident & emergency (A&E), General Practitioner (GP) attendances due to RRP symptoms.	Over study duration (53 months)
Impact of COVID	Test results, antibody results, symptoms, changes to management,	From March 2020 onwards (30 months)

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: National Institute for Health Research, United Kingdom; Alder Hey Children's NHS Foundation Trust
• Investigators: Principal Investigator: Adam Donne, Alder Hey Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Recurrent respiratory papillomatosis
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Recurrence; Respiratory Tract Infections; Papillomavirus Infections; Papilloma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Protective Agents; Dermatologic Agents; Cytochrome P-450 Enzyme Inhibitors; Reproductive Control Agents; Antiprotozoal Agents; Antiparasitic Agents; Cyclooxygenase 2 Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Anticarcinogenic Agents; Antimalarials; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Interferons; Interferon-alpha; Celecoxib; Methotrexate; Isotretinoin; Cidofovir; Acyclovir; Cimetidine; Artemisinins; Artemisinin; Indole-3-carbinol
• Other Study ID Numbers: 08733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No