First-Line Advanced Melanoma Chart Review Study, Version 1.0
Research type
Research Study
Full title
RETROSPECTIVE CHART REVIEW STUDY OF FIRST-LINE TREATMENT PATTERNS AND CLINICAL OUTCOMES IN PATIENTS WITH ADVANCED (UNRESECTABLE OR METASTATIC) MELANOMA IN THE UNITED KINGDOM
IRAS ID
233586
Contact name
Pippa Corrie
Contact email
Sponsor organisation
Bristol-Myers Squibb
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
With the recent and continued emergence of new first-line targeted and immunotherapies for the treatment of advanced melanoma, real-world data on current clinical practice patterns and outcomes are needed to better understand the first-line treatment landscape.
A multi-centre, retrospective chart review study will be undertaken in the UK to generate real-world evidence on first-line practice patterns including the evaluation of clinical and safety outcomes and healthcare resource utilisation in a subset of patients treated with first-line ipilimumab+nivolumab combination therapy.
This study will include adult patients with advanced (unresectable or metastatic) melanoma not previously treated for their advanced disease who started first-line therapy during the eligibility period (01 July 2016 to 01 July 2017) and meet all other inclusion/exclusion criteria. The target sample size is approximately 400 patients who initiated first-line therapy during the eligibility period across approximately 10 sites in UK (40-60 charts per site); target number of first-line ipilimumab+nivolumab combination therapy patients is 100 out of 400 patients.
Pseudomymised (anonymous to staff outside of the centre) data on demographics, disease characteristics, treatment history, treatment patterns, therapy sequencing, and disease progression status will be collected for all patients. Clinical outcomes (e.g., disease progression, treatment response), healthcare resource utilisation (e.g., hospitalisations, healthcare professional visits) and safety outcomes (e.g., side effects of interest, other serious side-effects and management of these side-effects) will be collected.
Data collected for this study is based on information pertaining to patient care already documented in patient medical charts. This study will not affect patient treatment, as it does not require any intervention and does not interfere with standard medical care.Data analyses will be descriptive in nature. Patient data will be stored securely and anonymously and will be used for research purposes. Study results will be summarised and included in presentations or publications.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1652
Date of REC Opinion
22 Sep 2017
REC opinion
Favourable Opinion