Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma

Introduction and hypotheses: The Outcomes Database to prospectivelY aSSEss the changing TherapY landscape in Renal Cell Carcinoma (ODYSSEY RCC) Registry is a large, nationally representative prospective registry of patients with metastatic renal cell carcinoma (mRCC) that aims to provide a real-world picture of longitudinal clinical management and patient experiences that impact clinical outcomes. The primary goal of this study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the USA. Design: This is an observational, phase 4 study with planned enrollment of up to 800 patients aged > 19 yr with mRCC in the USA. Patients will be identified through electronic health record (EHR) data from the PCORnet network of sites for care received at collaborating sites. A unique aspect of the study is the multiple data sources that will be linked to the EHR data. These include: (1) Medicare claims data, (2) laboratory results, (3) tissue specimens, (4) radiographic images, and (5) patient-reported outcomes, physicians' treatment selection, and discontinuation surveys. Protocol overview: We created a novel data resource that can inform patient care. Investigators have the opportunity to use these to study novel research questions after submitting an ancillary proposal and upon approval of the executive committee. Limitations include the potential for selection bias, residual confounding, and missing information. Summary: The ODYSSEY Registry will provide an advanced data resource that can examine numerous clinical questions related to patient and physician choice, and support methodological research related to omics and artificial intelligence. Patient summary: Cancer medications and treatments are changing rapidly. Collecting data on real-world clinical practice and patient-answered questionnaires will help us better understand cancer management and health-related quality of life while receiving metastatic renal cell carcinoma-specific treatment. (c) 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).