Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Patient Reported Outcomes And Treatment Experiences In Renal Cell Carcinoma (ONE-RCC)

Conditions
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Kidney Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Retrospective Long-term Chart Review | |
| Cohort 2<br>Prospective-Retrospective Chart Review and Humanistic Burden | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 36 months | 
| Disease-related symptoms as measured by change from baseline in FKSI-DRS |  | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of aRCC patients as measured by continuous statistics: Age |  | Up to 36 months | 
| Demographic characteristics of aRCC patients as measured by categorical statistics: Gender |  | Up to 36 months | 
| Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity |  | Up to 36 months | 
| Demographic characteristics of aRCC patients as measured by continuous statistics: Height |  | Up to 36 months | 
| Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status |  | Up to 36 months | 
| Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC |  | Up to 36 months | 
| Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug) |  | Up to 36 months | 
| Sequence of therapy events including treatment modalities |  | Up to 36 months | 
| Time to therapy initiation of LOT |  | Up to 36 months | 
| Rationale for therapy selection |  | Up to 36 months | 
| Switching and/or discontinuation rate |  | Up to 36 months | 
| Drug use characteristics including dosing regimens: Drugs included in each course of therapy |  | Up to 36 months | 
| Drug use characteristics including dosing regimens : Formulations |  | Up to 36 months | 
| Drug use characteristics including dosing regimens : Dose |  | Up to 36 months | 
| Drug use characteristics including dosing regimens : Frequency of administration |  | Up to 36 months | 
| Drug use characteristics including dosing regimens: Duration of therapy |  | Up to 36 months | 
| Drug use characteristics including dosing regimens : Number of cycles planned and administered |  | Up to 36 months |