Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
ODYSSEY RCC
1 other identifier
observational
468
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 11, 2026
August 1, 2025
4.8 years
May 24, 2021
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in medication adherence as measured by patient report.
Patient's report their medication at each study visit.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in quality of life in mRCC patients receiving therapy as measured by FKSI-19
The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in symptom burden in mRCC patients receiving therapy as measured by FKSI-19
The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in quality of life in mRCC patients receiving therapy as measured by FACT-G
The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in symptom burden in mRCC patients receiving therapy as measured by FACT-G
The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Secondary Outcomes (11)
First line management choice(s)
Up to 36 months
Subsequent line management choice(s)
Up to 36 months
Dosing (starting dose, dose intensity, ending dose)
Up to 36 months
Dose holds and dose interruptions
Up to 36 months
Time on treatment
Up to 36 months
- +6 more secondary outcomes
Study Arms (1)
Patients with mRCC with ≤ 3 mos of 1L or 2L systemic therapy
This is an observational cohort. * mRCC = metastatic renal cell cancer * 1L=first-line systemic therapy * 2L=second-line systemic therapy
Eligibility Criteria
Patients with metastatic renal cell cancer (mRCC) will be identified and undergo consent and baseline assessments, including research blood collection and processing. Patient reported outcomes will be collected at baseline (pre-treatment) every 3 months for 2 years, and then every 6 months until end of follow up (with a minimum follow-up of 18 months and a maximum follow-up period of 36 months; additional follow up will be obtained based on continuous funding).
You may qualify if:
- Age 19 or over at time of informed consent.
- Diagnosis of metastatic renal cell cancer (mRCC) with less than or equal to (≤) 3 months of first-line systemic therapy or less than or equal to (≤) 3 months of second-line systemic therapy for mRCC.
- Prior surgery and radiation therapy are permitted.
- Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted.
- Patients currently not on therapy and being observed are permitted.
- Evidence of signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- Ability to comply with completion of PROs
You may not qualify if:
- Patients being treated for metastatic solid tumors other than mRCC are excluded. Non-cytotoxic oral agents for adjuvant or maintenance therapy of other cancers are permitted.
- Patients who are not intending to undergo follow up care at a study site within PCORnet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Bristol-Myers Squibbcollaborator
- Duke Clinical Research Institutecollaborator
- Exelixiscollaborator
- Merck Sharp & Dohme LLCcollaborator
- Pfizercollaborator
Study Sites (14)
State University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Ochsner Clinic Foundation d/b/a Ochsner Health
New Orleans, Louisiana, 70121, United States
The Johns Hopkins University
Baltimore, Maryland, 21205, United States
The Regents of the University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Utah
Salt Lake City, Utah, 84112, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Bhavsar NA, Harrison MR, Scales CD, Zhang T, Troy J, Ward K, Jabusch SM, Lampron Z, George DJ. 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. Eur Urol Open Sci. 2024 Jul 3;66:75-81. doi: 10.1016/j.euros.2024.06.007. eCollection 2024 Aug.
PMID: 39070100BACKGROUNDGed Y, Markowski MC, Singla N, Rowe SP. The shifting treatment paradigm of metastatic renal cell carcinoma. Nat Rev Urol. 2022 Nov;19(11):631-632. doi: 10.1038/s41585-022-00651-9.
PMID: 36064785DERIVED
Biospecimen
36.5 mL of blood will be collected within (≤) 3 months of enrollment. Patients only receive a blood draw at their enrollment visit.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel George, MD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2021
First Posted
June 9, 2021
Study Start
April 1, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 11, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share