VOLUME-PRO
Research type
Research Study
Full title
niVOLUMab in the rEal world in patients with squamous cell carcinoma of the head & neck (SCCHN) – Patient Reported Outcomes (PRO)
IRAS ID
281449
Contact name
Robert Metcalf
Contact email
Sponsor organisation
Bristol-Myers Squibb Research and Development
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This is international observational study with a goal to collect data on treatment of recurrent/metastatic squamous cell carcinoma of the head and neck.
The main focus of this study is to describe the utilization of Nivolumab among patients. The aims of this study are to examine the demographic and clinical characteristics of patients with the above mentioned diagnose, as well as the patterns of Nivolumab use among them; to describe the treatment patterns of those who discontinue Nivolumab and to assess the correlation between patient reported outcomes (PROs) and clinical effectiveness of the therapy.
Questionnaires will be administrated to patients to evaluate their health-related quality of life at two timepoints: during enrollment and 6 to 8 weeks later as part of their standard of care visit.REC name
London - Chelsea Research Ethics Committee
REC reference
20/PR/0721
Date of REC Opinion
23 Dec 2020
REC opinion
Further Information Favourable Opinion