Real-world treatments & survival for advanced melanoma, RCC & SCCHN
Research type
Research Study
Full title
Retrospective study of treatment patterns and overall survival in patients with advanced melanoma, advanced renal cell carcinoma and metastatic squamous cell carcinoma of the head and neck in the United Kingdom
IRAS ID
257073
Contact name
Adrian Nicholson
Contact email
Sponsor organisation
Bristol-Myers Squibb Company
Duration of Study in the UK
3 years, months, days
Research summary
The purpose of this study is to describe how patients are treated for their cancer as well as their overall survival, following diagnoses of advanced skin cancer, kidney cancer or head and neck cancer. The minimum target sample size for this study is 200-300 patients for each of these cancers.
ChemoCare (owned by CIS-oncology), is a chemotherapy prescribing and patient management system used by 80% of the UK’s National Health Service (NHS) cancer centres. ChemoCare has been in use in the NHS for over 15 years. The data collected in this study will be electronically exported from the ChemoCare prescription platform by CIS-oncology. The exported data will be transferred to a secure server for analysis.
Data will be collected in waves:
Wave 1: Data collection will occur after centre set-up is complete. Data will be collected for patients previously treated with a first-line treatment for advanced skin cancer (since Aug 2016), kidney cancer (since Jul 2015) or head & neck cancer (since Nov 2016).
Waves 2-7: After the first wave, refresh data extraction will occur every 6 months for a period of up to 3 years. This will include: (i) data from new patients who began their first-line treatment (for advanced skin cancer, kidney cancer or head & neck cancer) since the prior wave and (ii) follow-up of the treatments prescribed and survival of patients whose data was already collected in a prior waves.
Only data from the past will be collected in each wave (i.e., medical events will have already taken place and be recorded in ChemoCare at the time the data are extracted).Data analyses will be descriptive. Patient data will be transferred and stored securely without any patient identifiable information so that patient privacy is protected. Study results will be summarised and included in presentations and publications.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0083
Date of REC Opinion
25 Mar 2019
REC opinion
Favourable Opinion