Recurrent Respiratory PapillomatosisAIR:RRPNCT03465280
Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)
An observational study of Recurrent Respiratory Papillomatosis and Human Papilloma Virus, run by Newcastle-upon-Tyne Hospitals NHS Trust at 48 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Respiratory Papillomatosis, Human Papilloma Virus
- What is being tested?
- Microdebrider, Cold-steel surgery (forceps) and Carbon dioxide laser
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 48 sitesUnited Kingdom
- Study dates
- 1 Apr 2018to 31 Aug 2022
- How long will I take part?
- 53 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with respiratory papillomatosis receiving hospital treatment
Who may be able to join
- 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
Who cannot join
- patients participating in other studies
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United Kingdom48 sites, 48 recruiting
- Recruiting
NHS Grampian
Aberdeen, AB25 2ZB
- Recruiting
Betsi Cadwaladr University Health Board,
Bangor, LL57 2PW
- Recruiting
Basildon & Thurrock University Hospitals NHS FT
Basildon, SS165NL
- Recruiting
Belfast Health and Social Care Trust
Belfast, BT2 8BG
- Recruiting
University Hospital Birmingham NHS Foundation Trust
Birmingham, B15 2GW
- Recruiting
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, B4 6NH
- Recruiting
Blackpool Teaching Hospital NHS FT
Blackpool, FY38NR
- Recruiting
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
- Recruiting
Cardiff and Vale University Local Health Board
Cardiff, CF14 4XW
- Recruiting
North Cumbria Univeristy Hospital NHS Trust
Carlisle, CA27HY
- Recruiting
Hywel Dda University Health Board
Carmarthen, SA31 3BB
- Recruiting
County Durham and Darlington NHS Foundation Trust
Darlington, DL36HX
- Recruiting
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, DE223NE
- Recruiting
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, DN2 5LT
- Recruiting
NHS Tayside
Dundee, DD2 1GZ
- Recruiting
NHS Lothian
Edinburgh, EH16 4TJ
- Recruiting
Frimley Health NHS Foundation Trust
Frimley, GU16 7UJ
- Recruiting
NHS Greater Glasgow & Clyde
Glasgow, G120XH
- Recruiting
London North West University Healthcare NHS Trust
Harrow, HA1 3UJ
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
- Recruiting
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 2AP
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8XP
- Recruiting
Barts Health NHS Trust
London, E1 2ES
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
- Recruiting
Lewisham and Greenwich NHS Trust
London, SE13 6LH
- Recruiting
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
- Recruiting
Imperial College Healthcare NHS Trust
London, W2 1NY
- Recruiting
Great Ormond Street Hospital for Children NHS FT
London, WC1N3JH
- Recruiting
Bedfordshire Hospitals NHS Foundation Trust
Luton, LU4 0DZ
- Recruiting
Manchester University Hospital NHS Foundation Trust
Manchester, M13 9WL
- Recruiting
Pennine Acute Hospitals NHS Trust
Manchester, M8 5RB
- Recruiting
Wirral University Teaching Hospitals NHS Foundation Trust
Metropolitan Borough of Wirral, CH49 5PE
- Recruiting
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Andrew Sims, nuth.NMPCE.Air@nhs.net
- Recruiting
Isle of Wight NHS Trust
Newport, PO30 5TG
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG51PB
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
- Recruiting
University Hospital of Plymouth NHS Trust
Plymouth, PL6 8DH
- Recruiting
Swansea Bay University Health Board
Port Talbot, SA12 7BR
- Recruiting
East Sussex Healthcare NHS Trust
Saint Leonards-on-Sea, TN37 7PT
- Recruiting
Salford Royal NHS Foundation Trust
Salford, M6 8HD
- Recruiting
Sheffield Children's NHS Foundation Trust
Sheffield, S10 2TH
- Recruiting
The Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, SY3 8XQ
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
- Recruiting
Stockport NHS Foundation Trust
Stockport, SK2 7JE
- Recruiting
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, SR4 7TP
About this study
Official title: 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.
Read the 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.
- Being tested
- Microdebrider, Cold-steel surgery (forceps), Carbon dioxide laser, Potassium titanyl phosphate (KTP) laser, Pulsed dye laser
- Keywords
- Recurrent respiratory papillomatosis
- Medical subject headings
- Recurrent respiratory papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodebriderProcedure or surgery
Removal of lesions via microdebrider
Cold-steel surgery (forceps)Procedure or surgery
Removal of lesions via forceps
Carbon dioxide laserProcedure or surgery
Removal of lesions via carbon dioxide laser
Potassium titanyl phosphate (KTP) laserProcedure or surgery
Removal of lesions via KTP laser
Pulsed dye laserProcedure or surgery
Removal of lesions via pulsed dye laser
Radiofrequency ablationProcedure or surgery
Removal of lesions via radiofrequency ablation
Monopolar suction diathermyProcedure or surgery
Removal of lesions via monopolar suction diathermy
Plasma coagulationProcedure or surgery
Removal of lesions via plasma coagulation
OtherProcedure or surgery
Removal of lesions via other methods
Adjuvant therapiesOther
Also called Acyclovir, Artemisinin, Bevacizumab (Avastin), Celecoxib (Celebrex)
All adjuvant therapies
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval between surgical interventions
Time between surgical interventions to maintain symptomatic control
Measured: Over study duration (53 months)
Secondary outcomes (14)
RRP surgical intervention - nature
Nature of intervention
Measured: Over study duration (53 months)
RRP surgical intervention - timing
Timing of intervention
Measured: Over study duration (53 months)
RRP adjuvant therapy - nature
Nature of intervention
Measured: Over study duration (53 months)
RRP adjuvant therapy - timing
Timing of intervention
Measured: Over study duration (53 months)
Histology results
Including HPV type
Measured: 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)
Measured: Over study duration (53 months)
Number of hospital visits/attendances
Inpatient, Accident \& emergency, Outpatient
Measured: Over study duration (53 months)
Voice assessment (paediatric)
Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)
Measured: Over study duration (53 months)
Voice assessment (adult)
Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)
Measured: Over study duration (53 months)
Short-term complications
Complications arising in-hospital
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Over study duration (53 months)
Impact of COVID
Test results, antibody results, symptoms, changes to management,
Measured: From March 2020 onwards (30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Apr 2018
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 53 Months
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Adam Donne, Principal investigator, Alder Hey Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465280
- Sponsor's protocol ID
- 08733
- Acronym
- AIR:RRP
- Status last verified
- Jan 2022
- First submitted
- 26 Feb 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Donne AJ, Keltie K, Burn J, Belilios E, Powell S, Cognigni P, Nixon IJ, Bateman N, Kubba H, Judd O, Sims A. Current Practice, Safety and Efficacy of Interventions for Recurrent Respiratory Papillomatosis: Evidence From a UK Registry. Clin Otolaryngol. 2025 Mar;50(2):271-279. doi: 10.1111/coa.14245. Epub 2024 Oct 24.
PubMed 39445512
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis
- ClinicalTrials.gov ID
- NCT03465280
- Acronym / sponsor ID
- AIR:RRP / 08733
- Keywords
- Recurrent respiratory papillomatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 53 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with respiratory papillomatosis receiving hospital treatment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patients participating in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrodebriderRemoval of lesions via microdebrider | Procedure or surgery | – |
| Cold-steel surgery (forceps)Removal of lesions via forceps | Procedure or surgery | – |
| Carbon dioxide laserRemoval of lesions via carbon dioxide laser | Procedure or surgery | – |
| Potassium titanyl phosphate (KTP) laserRemoval of lesions via KTP laser | Procedure or surgery | – |
| Pulsed dye laserRemoval of lesions via pulsed dye laser | Procedure or surgery | – |
| Radiofrequency ablationRemoval of lesions via radiofrequency ablation | Procedure or surgery | – |
| Monopolar suction diathermyRemoval of lesions via monopolar suction diathermy | Procedure or surgery | – |
| Plasma coagulationRemoval of lesions via plasma coagulation | Procedure or surgery | – |
| OtherRemoval of lesions via other methods | Procedure or surgery | – |
| Adjuvant therapiesAlso: Acyclovir, Artemisinin, Bevacizumab (Avastin), Celecoxib (Celebrex)All adjuvant therapies | Other | – |
Primary outcome
Time interval between surgical interventions
Time frame: Over study duration (53 months)
Time between surgical interventions to maintain symptomatic control
14 secondary outcomes
RRP surgical intervention - nature
Time frame: Over study duration (53 months)
RRP surgical intervention - timing
Time frame: Over study duration (53 months)
RRP adjuvant therapy - nature
Time frame: Over study duration (53 months)
RRP adjuvant therapy - timing
Time frame: Over study duration (53 months)
Histology results
Time frame: Over study duration (53 months)
Severity of papillomas
Time frame: Over study duration (53 months)
Number of hospital visits/attendances
Time frame: Over study duration (53 months)
Voice assessment (paediatric)
Time frame: Over study duration (53 months)
Voice assessment (adult)
Time frame: Over study duration (53 months)
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)
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)
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)
Long-term complications
Time frame: Over study duration (53 months)
Impact of COVID
Time frame: From March 2020 onwards (30 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 39445512Donne AJ, Keltie K, Burn J, Belilios E, Powell S, Cognigni P, Nixon IJ, Bateman N, Kubba H, Judd O, Sims A. Current Practice, Safety and Efficacy of Interventions for Recurrent Respiratory Papillomatosis: Evidence From a UK Registry. Clin Otolaryngol. 2025 Mar;50(2):271-279. doi: 10.1111/coa.14245. Epub 2024 Oct 24.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Donne principal investigator
Alder Hey Children's NHS Foundation Trust
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Respiratory Papillomatosis and Human Papilloma Virus, run by Newcastle-upon-Tyne Hospitals NHS Trust at 48 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Sims (0191 244 8738, nuth.NMPCE.Air@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval between surgical interventions (time frame: Over study duration (53 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.