Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Surgeries or surgeries plus adjuvant therapies

Surgeries

Lunxun Liu, PhD

The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors

The trial is a multi-centre real-world non-interventional observational study to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors via a retrospectively review method on the study data on patient demographic/tumor biological characteristics and clinical treatments.

A Study to Evaluate Clinical Characteristics of Lung Cancer in Patients With Surgeries and Adjuvant Therapies

A Multi-centre Real-world Non-interventional Observational Study to Evaluate Clinical Characteristics of the Chinese Patients With Lung Malignant Tumors Who Received Surgeries or Surgeries Plus Adjuvant Therapies

Differences in perioperative overall survivals and overall survivals of the patients who received surgeries of thoracotomy, video-assistant thoracic surgery or robotic thoracic surgery

Impact factors of patient survival in patients with tumor size =\<2 cm who received surgeries as measured by tumor clinical/pathological staging

Impact factors of patient survival in patients with tumor size =\<2 cm who received surgeries as measured by location of tumors and tumor sizes

Impact factors of patient survival in patients with tumor size =\<2 cm who received surgeries as measured by duration and modes of surgeries

Impact factors of patient survival in patients with tumor size =\<2 cm who received surgeries as measured by type of insurances

Overall survival in the patients with tumor size =\< 2cm who received surgeries

Impact factors of patient survivals in the patients with N2 lung cancer who received surgeries or surgeries plus adjuvant therapies

Overall survival in the patients with N2 lung cancer who received surgeries or surgeries plus adjuvant therapies

Impact factors of patient survivals in the patients with small lung cancer who received surgeries or surgeries plus adjuvant therapies

Overall survival in the patients with small lung cancer who received surgeries or surgeries plus adjuvant therapies

Demographic characteristics of the patients with non-small cell lung cancer who were treated with chemotherapies, tyrosine kinase inhibitors, and other adjuvant therapies or were not treated with adjuvant therapies as measured by:

* Age
* Gender
* Payment types
* Insurance types
* Smoking history
* Complications and symptoms of complications
* Respiratory functions
* Type of diagnoses

Demographic characteristics of the patients with lung malignant tumors who received surgeries of thoracotomy, video-assistant thoracic surgery or robotic thoracic surgery as measured by:

* Age
* Gender
* Payment types
* Insurance types
* Smoking history
* Complications and symptoms of complications
* Respiratory functions
* Type of diagnoses

LinkDoc Technology (Beijing) Co. Ltd.

West China Hospital

Professor

Symptoms and General Pathology

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Virus Diseases

Papilloma

Communicable Diseases

Respiratory Tract Infections

Papillomavirus Infections

Disease Attributes

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Recurrent Respiratory Papillomatosis

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Anti-Inflammatory Agents

Analgesics

Gastrointestinal Agents

Micronutrients

Hematinics

Other Dietary Supplements

Vitamins

Bevacizumab

Methotrexate

Acyclovir

Celecoxib

Isotretinoin

Interferons

Tretinoin

Interferon-alpha

Interferon-alfa-1b

Artemisinins

Artemisinin

Cimetidine

Cidofovir

Indole-3-carbinol

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Antacids

Anti-Ulcer Agents

Histamine

Histamine H2 Antagonists

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Cytochrome P-450 Enzyme Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Protective Agents

Indole

Folinic Acid

Folate

Vitamin B9

Microdebrider

Cold-steel surgery (forceps)

Removal of lesions via carbon dioxide laser

Carbon dioxide laser

Potassium titanyl phosphate (KTP) laser

Pulsed dye laser

Removal of lesions via radiofrequency ablation

Radiofrequency ablation

Removal of lesions via monopolar suction diathermy

Monopolar suction diathermy

Removal of lesions via plasma coagulation

Plasma coagulation

Other

Adjuvant therapies

Andrew Sims

Adam Donne

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.

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.

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

Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis

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.

Time between surgical interventions to maintain symptomatic control

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)

Inpatient, Accident \& emergency, Outpatient

Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)

Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)

Planned discharge location (decided pre-operation)

Actual discharge location (occurring post-operation)

Unexpected hospital, Accident \& emergency (A\&E), General Practitioner (GP) attendances due to RRP symptoms.

Test results, antibody results, symptoms, changes to management,

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Clinical Characteristics of Lung Cancer in Patients With Surgeries and Adjuvant Therapies	NCT03421093	Lung Cancer	Surgeries	18 Years -	West China Hospital
Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)	NCT03465280	Recurrent Respi... Human Papilloma...	Microdebrider Cold-steel surg... Carbon dioxide ... Potassium titan... Pulsed dye lase... Radiofrequency ... Monopolar sucti... Plasma coagulat... Other Adjuvant therap...	-	Newcastle-upon-Tyne Hospitals NHS Trust
Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)	NCT03465280	Recurrent Respi... Human Papilloma...	Microdebrider Cold-steel surg... Carbon dioxide ... Potassium titan... Pulsed dye lase... Radiofrequency ... Monopolar sucti... Plasma coagulat... Other Adjuvant therap...	-	Newcastle-upon-Tyne Hospitals NHS Trust

Spots Global Cancer Trial Database for adjuvant therapies