Observational study in R/M SCCHN V18Dec2018
Research type
Research Study
Full title
Treatment patterns, clinical outcomes, resource utilization, and patient reported outcomes in first-line recurrent/metastatic squamous cell carcinoma of the head and neck (1L R/M SCCHN) patients in Europe
IRAS ID
258057
Contact name
Prianka Singh
Contact email
Sponsor organisation
Bristol-Myers Squibb Research and Development
Clinicaltrials.gov Identifier
19/NW/0242,
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
This is a two-cohort observational study as follows: Note that for the purposes of this study, R/M SCCHN is defined as locoregional recurrence (defined as recurrence in the same region of the body), metastatic recurrence, or newly diagnosed metastatic disease.
• For Cohort 1 (chart review), we will implement a retrospective, observational, medical chart review study of patients diagnosed with R/M SCCHN between 01-Jan-2014 and 31-Dec-2016, to determine patient and clinical characteristics, 1L treatment patterns, HCRU, and response to treatment. Patients that are alive and not lost to follow-up at time of enrollment will be followed up at 24 weeks post study enrollment to ensure a minimum of 24 months of data censoring for death, following diagnosis of R/M SCCHN.
• For Cohort 2 (PRO/QoL), we will implement a prospective, observational, longitudinal PRO survey study of patients newly initiating 1L treatment after 01-Aug-2018 for R/M SCCHN. Patients will complete PRO/QoL surveys at study enrollment and 15 weeks after initiation (planned follow-up is based on BMS clinical trial).REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0242
Date of REC Opinion
13 May 2019
REC opinion
Unfavourable Opinion