The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
Official Title: Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
Study ID: NCT04919122
Brief Summary: ODYSSEY RCC is a prospective, observational Phase IV 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 United States, including both community and academic treatment settings.
Detailed Description: This trial is a prospective, observational Phase IV 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 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 physician selection of particular agents, and discontinuation of therapies. The primary objective is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy. Patients will be identified and undergo consent and baseline assessments, including research blood collection and processing, by the study site team, this baseline visit will be their only clinic visits per protocol. All other visits are standard of care visits and outside the scope of the study. Subsequent follow up with be coordinated centrally by DCRI. Additional clinic data will be obtained via PCORnet data pull and Medicare claims. Patient reported outcomes, quality of life and medications data will be obtained via the DCRI Call Center through follow-up phone interviews.
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
State University of Iowa, Iowa City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
The Johns Hopkins University, Baltimore, Maryland, United States
The Regents of the University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Duke University, Durham, North Carolina, United States
Geisinger Clinic, Danville, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Utah, Salt Lake City, Utah, United States
The Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, United States
Name: Daniel George, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR