Evaluating Real-World Clinical Practice Data of Patients With Metastatic RCC

The Outcomes Database to prospectivelY aSSEss the changing TherapY landscape in Renal Cell Carcinoma (ODYSSEY RCC) is a prospective registry seeking to determine the real-world picture of longitudinal clinical management and experiences impacting clinical outcomes for patients with metastatic RCC (mRCC).

In a phase 4, observational study, Nrupen A. Bhavsar, PhD, and colleagues are investigating cancer management and health-related quality of life for patients with mRCC across routine real-world clinical practice in the United States. The study’s secondary end point is time to treatment discontinuation.

The design and rationale of the investigation were published in European Urology Open Science.

Within a 21-month period, Dr. Bhavsar and colleagues are planning to enroll up to 800 patients with mRCC who are older than 19 years of age and reside in the United States. Prospective patients will be selected using electronic health records (EHR) collected from the National Patient-Centered Clinical Research Network.

The EHR data will include multiple data sources, such as Medicare claims data, laboratory results, tissue specimens, radiographic images, patient-reported outcomes, physicians’ treatment selection, and discontinuation surveys.

Researchers stated that the novel data source has the potential to inform patient care. They noted that following the submission of an ancillary proposal and approval from the executive committee, investigators may be allowed to use the resource to study novel research questions.

Potential limiting factors include selection bias, residual confounding, and missing information.

“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,” investigators wrote.