Kidney Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Demographic characteristics of aRCC patients as measured by continuous statistics: Age | 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 |
| Rationale for therapy selection | Up to 36 months |
| Demographic characteristics of aRCC patients as measured by categorical statistics: Gender | Up to 36 months |
Countries
United States
Outcome results
None listed