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

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ClinicalTrials.gov Identifier: NCT03465280
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
Alder Hey Children's NHS Foundation Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Study Description
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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 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.

Condition or disease Intervention/treatment
Recurrent Respiratory Papillomatosis Human Papilloma Virus 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

Detailed Description:

Primary aim:

The overall goal is to improve the care of children 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 paediatric 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.

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 aged 16 years or less receiving treatment in any UK NHS hospital will be eligible for inclusion. Data collection will be open for 32 months with no minimum follow-up required for patients. As RRP is more aggressive and common in children and 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 children in the UK. Consent will be required (from patients/parent/guardian) before data are entered into the online database.


Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 32 Months
Official Title: Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. Time interval between surgical interventions [ Time Frame: Over study duration (32 months) ]
    Time between surgical interventions to maintain symptomatic control


Secondary Outcome Measures :
  1. RRP surgical intervention - nature [ Time Frame: Over study duration (32 months) ]
    Nature of intervention

  2. RRP surgical intervention - timing [ Time Frame: Over study duration (32 months) ]
    Timing of intervention

  3. RRP adjuvant therapy - nature [ Time Frame: Over study duration (32 months) ]
    Nature of intervention

  4. RRP adjuvant therapy - timing [ Time Frame: Over study duration (32 months) ]
    Timing of intervention

  5. Histology results [ Time Frame: Over study duration (32 months) ]
    Including HPV type

  6. Severity of papillomas [ Time Frame: Over study duration (32 months) ]
    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)

  7. Number of hospital visits/attendances [ Time Frame: Over study duration (32 months) ]
    Inpatient, Accident & emergency, Outpatient

  8. Voice assessment (paediatric) [ Time Frame: Over study duration (32 months) ]
    Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)

  9. Voice assessment (adult) [ Time Frame: Over study duration (32 months) ]
    Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)

  10. Short-term complications [ Time Frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days) ]
    Complications arising in-hospital

  11. Post-operative discharge location - planned [ Time Frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days) ]
    Planned discharge location (decided pre-operation)

  12. Post-operative discharge location - actual [ Time Frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days) ]
    Actual discharge location (occurring post-operation)

  13. Long-term complications [ Time Frame: Over study duration (32 months) ]
    Unexpected hospital, Accident & emergency (A&E), General Practitioner (GP) attendances due to RRP symptoms.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with respiratory papillomatosis receiving hospital treatment
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465280


Contacts
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Contact: Andrew Sims 0191 244 8738 nmpce.air@nuth.nhs.uk

Locations
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United Kingdom
NHS Grampian Recruiting
Aberdeen, United Kingdom, AB25 2ZB
Betsi Cadwaladr University Health Board, Recruiting
Bangor, United Kingdom, LL57 2PW
Basildon & Thurrock University Hospitals NHS FT Recruiting
Basildon, United Kingdom, SS165NL
Belfast Health and Social Care Trust Recruiting
Belfast, United Kingdom, BT2 8BG
University Hospital Birmingham NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B15 2GW
Birmingham Women's and Children's NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B4 6NH
Blackpool Teaching Hospital NHS FT Recruiting
Blackpool, United Kingdom, FY38NR
Bradford Teaching Hospitals NHS Foundation Trust Recruiting
Bradford, United Kingdom, BD9 6RJ
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Cardiff and Vale University Local Health Board Recruiting
Cardiff, United Kingdom, CF14 4XW
North Cumbria Univeristy Hospital NHS Trust Recruiting
Carlisle, United Kingdom, CA27HY
Hywel Dda University Health Board Recruiting
Carmarthen, United Kingdom, SA31 3BB
County Durham and Darlington NHS Foundation Trust Recruiting
Darlington, United Kingdom, DL36HX
Derby Teaching Hospitals NHS Foundation Trust Recruiting
Derby, United Kingdom, DE223NE
NHS Tayside Recruiting
Dundee, United Kingdom, DD2 1GZ
NHS Lothian Recruiting
Edinburgh, United Kingdom, EH16 4TJ
Frimley Health NHS Foundation Trust Recruiting
Frimley, United Kingdom, GU16 7UJ
NHS Greater Glasgow & Clyde Recruiting
Glasgow, United Kingdom, G120XH
London North West University Healthcare NHS Trust Recruiting
Harrow, United Kingdom, HA1 3UJ
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Alder Hey Children's NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L12 2AP
Aintree University Hospitals NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L9 7AL
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 2ES
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2PG
Lewisham and Greenwich NHS Trust Recruiting
London, United Kingdom, SE13 6LH
St George's University Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, SW17 0QT
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W2 1NY
Great Ormond Street Hospital for Children NHS FT Recruiting
London, United Kingdom, WC1N3JH
Manchester University Hospital NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
Pennine Acute Hospitals NHS Trust Recruiting
Manchester, United Kingdom, M8 5RB
South Tees Hospitals NHS Foundation Trust Recruiting
Middlesbrough, United Kingdom, TS4 3BW
The Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Andrew Sims       nmpce.air@nuth.nhs.uk   
Isle of Wight NHS Trust Recruiting
Newport, United Kingdom, PO30 5TG
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG51PB
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX3 9DU
University Hospital of Plymouth NHS Trust Recruiting
Plymouth, United Kingdom, PL6 8DH
Abertawe Bro Morgannwg University Local Health Board Recruiting
Port Talbot, United Kingdom, SA12 7BR
East Sussex Healthcare NHS Trust Recruiting
Saint Leonards-on-Sea, United Kingdom, TN37 7PT
Salford Royal NHS Foundation Trust Recruiting
Salford, United Kingdom, M6 8HD
Sheffield Children's NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2TH
The Shrewsbury and Telford Hospital NHS Trust Recruiting
Shrewsbury, United Kingdom, SY3 8XQ
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom, SO16 6YD
City Hospitals Sunderland NHS Foundation Trust Recruiting
Sunderland, United Kingdom, SR4 7TP
Wirral University Teaching Hospitals NHS Foundation Trust Recruiting
Wirral, United Kingdom, CH49 5PE
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Alder Hey Children's NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Adam Donne Alder Hey Children's NHS Foundation Trust
More Information
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Additional Information:

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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03465280     History of Changes
Other Study ID Numbers: 08733
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Recurrent respiratory papillomatosis
Additional relevant MeSH terms:
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Respiratory Tract Infections
Papillomavirus Infections
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections