Clinical trial · Observational
Participant Reported Outcomes and Treatment Experiences in Kidney Cancer
Patient Reported Outcomes And Treatment Experiences In Renal Cell Carcinoma (ONE-RCC)
NCT04472663CI-TRIAL-00058040completedClinicalTrials.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)
The purpose of this observational study is to collect contemporary real-world treatment patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or adverse reactions (ARs) among Advanced Renal Cell Carcinoma (aRCC) patients initiating first-line systemic therapy.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Retrospective Long-term Chart Review
- label
- Cohort 2
- description
- Prospective-Retrospective Chart Review and Humanistic Burden
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 36 months
- measure
- Disease-related symptoms as measured by change from baseline in FKSI-DRS
- timeFrame
- Up to 36 months
Secondary outcomes (17)
- measure
- Demographic characteristics of aRCC patients as measured by continuous statistics: Age
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Cohort 1 * Primary diagnosis of aRCC (advanced Renal Cell Carcinoma) or metastatic RCC * Medical history must be available from date of aRCC diagnosis * Initiated 1LOT between April 2018 - March 2020 Cohort 2: * Primary diagnosis of aRCC (not amenable to curative surgery or radiation therapy/ AJCC Stage III unresectable) or metastatic RCC (AJCC Stage IV). * Medical history must be available from date of aRCC diagnosis. * Initiate 1LOT. Exclusion Criteria: * Currently enrolled in a clinical trial for treatment of aRCC * Any prior malignancy active within the previous 3 year, except for locally curable cancers that have been cured * Any prior systemic therapy for aRCC, with the exception of neoadjuvant or adjuvant therapy (Cohort 2 only) Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.