Clinical trial · Observational
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
NCT04919122CI-TRIAL-00120586ODYSSEY RCCactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with mRCC with ≤ 3 mos of 1L or 2L systemic therapy
- description
- This is an observational cohort. * mRCC = metastatic renal cell cancer * 1L=first-line systemic therapy * 2L=second-line systemic therapy
Primary outcomes (5)
- measure
- Change in medication adherence as measured by patient report.
- timeFrame
- baseline, every 3 months for 2 years, every 6 months for up to 36 months
- description
- Patient's report their medication at each study visit.
- measure
- Change in quality of life in mRCC patients receiving therapy as measured by FKSI-19
- timeFrame
- baseline, every 3 months for 2 years, every 6 months for up to 36 months
- description
- The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 1. Prior surgery and radiation therapy are permitted. 2. Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted. 3. 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 Exclusion Criteria: * 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
References
Publications (2)
- BACKGROUNDBhavsar 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 39070100
- DERIVEDGed 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 36064785