Outcomes Database to prospectivelY aSSEss changing TherapY landscape in Renal Cell Carcinoma (Odyssey)

PI(s): Dan George, Duke University

Project Summary: The primary goal of this prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with metastatic renal cell carcinoma (mRCC) in routine real-world clinical practice in the United States, including both community and academic treatment settings. Primarily, the study will evaluate patient experience through collection of patient-reported outcomes (PROs). The study will also collect and assess information on the therapies used such as first-line treatment selection, treatment sequence and duration, the drivers of physicians’ choices of therapies, and discontinuation of therapies. By comparing the combination therapies in a real-world setting, the researchers hope to better inform patients and their providers about treatment choices. This study aims to:

• Determine distinct patterns of change in patient-reported outcome measures in patients receiving immune-oncology (IO) therapies versus a combination of IO/TKI (tyrosine kinase inhibitors) therapies
• Define the clinical course of patients on IO/IO versus IO/TKI combinations
• Understand the treatment preferences of both physicians and patients

Study Design: Multi-CRN Observational Studies Requiring Recruitment

PaTH Partners:

• University of Pittsburgh (Roby Thomas, Site PI)
• Geisinger Health System (Raghava Levaka, Site PI)
• University of Michigan (Ajjai Alva, Site PI)
• Johns Hopkins University (Yasser Ged, Site PI)

Sponsor: PCORI®