NCT03465280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

48 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4.4 years

First QC Date

February 26, 2018

Last Update Submit

January 10, 2022

Conditions

Keywords

Recurrent respiratory papillomatosis

Outcome Measures

Primary Outcomes (1)

  • Time interval between surgical interventions

    Time between surgical interventions to maintain symptomatic control

    Over study duration (53 months)

Secondary Outcomes (14)

  • RRP surgical intervention - nature

    Over study duration (53 months)

  • RRP surgical intervention - timing

    Over study duration (53 months)

  • RRP adjuvant therapy - nature

    Over study duration (53 months)

  • RRP adjuvant therapy - timing

    Over study duration (53 months)

  • Histology results

    Over study duration (53 months)

  • +9 more secondary outcomes

Interventions

MicrodebriderPROCEDURE

Removal of lesions via microdebrider

Removal of lesions via forceps

Removal of lesions via carbon dioxide laser

Removal of lesions via KTP laser

Removal of lesions via pulsed dye laser

Removal of lesions via radiofrequency ablation

Removal of lesions via monopolar suction diathermy

Removal of lesions via plasma coagulation

OtherPROCEDURE

Removal of lesions via other methods

All adjuvant therapies

Also known as: Acyclovir, Artemisinin, Bevacizumab (Avastin), Celecoxib (Celebrex), Cidofovir, Cimetidine, Di-indolmethane (DIM), Gardasil, Indole-3-carbinol (I3C), alpha-Interferon, PEG-Interferon, Methotrexate, Retinoic acid (isotretinoin), Ribavarin, Other

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with respiratory papillomatosis receiving hospital treatment

You may qualify if:

  • 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

You may not qualify if:

  • patients participating in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

NHS Grampian

Aberdeen, AB25 2ZB, United Kingdom

RECRUITING

Betsi Cadwaladr University Health Board,

Bangor, LL57 2PW, United Kingdom

RECRUITING

Basildon & Thurrock University Hospitals NHS FT

Basildon, SS165NL, United Kingdom

RECRUITING

Belfast Health and Social Care Trust

Belfast, BT2 8BG, United Kingdom

RECRUITING

University Hospital Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

RECRUITING

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, B4 6NH, United Kingdom

RECRUITING

Blackpool Teaching Hospital NHS FT

Blackpool, FY38NR, United Kingdom

RECRUITING

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD9 6RJ, United Kingdom

RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Cardiff and Vale University Local Health Board

Cardiff, CF14 4XW, United Kingdom

RECRUITING

North Cumbria Univeristy Hospital NHS Trust

Carlisle, CA27HY, United Kingdom

RECRUITING

Hywel Dda University Health Board

Carmarthen, SA31 3BB, United Kingdom

RECRUITING

County Durham and Darlington NHS Foundation Trust

Darlington, DL36HX, United Kingdom

RECRUITING

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, DE223NE, United Kingdom

RECRUITING

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, DN2 5LT, United Kingdom

RECRUITING

NHS Tayside

Dundee, DD2 1GZ, United Kingdom

RECRUITING

NHS Lothian

Edinburgh, EH16 4TJ, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust

Frimley, GU16 7UJ, United Kingdom

RECRUITING

NHS Greater Glasgow & Clyde

Glasgow, G120XH, United Kingdom

RECRUITING

London North West University Healthcare NHS Trust

Harrow, HA1 3UJ, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Alder Hey Children's NHS Foundation Trust

Liverpool, L12 2AP, United Kingdom

RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 2ES, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Lewisham and Greenwich NHS Trust

London, SE13 6LH, United Kingdom

RECRUITING

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children NHS FT

London, WC1N3JH, United Kingdom

RECRUITING

Bedfordshire Hospitals NHS Foundation Trust

Luton, LU4 0DZ, United Kingdom

RECRUITING

Manchester University Hospital NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Pennine Acute Hospitals NHS Trust

Manchester, M8 5RB, United Kingdom

RECRUITING

Wirral University Teaching Hospitals NHS Foundation Trust

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

RECRUITING

South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Isle of Wight NHS Trust

Newport, PO30 5TG, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG51PB, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

RECRUITING

University Hospital of Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Swansea Bay University Health Board

Port Talbot, SA12 7BR, United Kingdom

RECRUITING

East Sussex Healthcare NHS Trust

Saint Leonards-on-Sea, TN37 7PT, United Kingdom

RECRUITING

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

RECRUITING

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

RECRUITING

The Shrewsbury and Telford Hospital NHS Trust

Shrewsbury, SY3 8XQ, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

Stockport NHS Foundation Trust

Stockport, SK2 7JE, United Kingdom

RECRUITING

South Tyneside and Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Recurrent respiratory papillomatosis

Interventions

Surgical InstrumentsLasers, Gaspotassium titanylphosphateLasersLasers, DyeRadiofrequency AblationAcyclovirartemisininBevacizumabCelecoxibCidofovirCimetidineHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18indole-3-carbinolInterferon-alphaMethotrexateTretinoinIsotretinoin

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and SuppliesOptical DevicesRadiation Equipment and SuppliesRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingOrganophosphonatesOrganophosphorus CompoundsCytosinePyrimidinonesPyrimidinesGuanidinesAmidinesImidazolesVaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral VaccinesInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsAminopterinPterinsPteridinesVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesDiterpenesPigments, Biological

Study Officials

  • Adam Donne

    Alder Hey Children's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
53 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 14, 2018

Study Start

April 1, 2018

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

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.

Locations