Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

Bristol-Myers Squibb5 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Kidney Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Morristown, New Jersey, United States

Outcomes

Primary Outcomes

Overall Survival (OS)

Time frame: Up to 36 months

Disease-related symptoms as measured by change from baseline in FKSI-DRS

Time frame: Up to 36 months

Secondary Outcomes

Demographic characteristics of aRCC patients as measured by continuous statistics: Age

Time frame: Up to 36 months

Demographic characteristics of aRCC patients as measured by categorical statistics: Gender

Time frame: Up to 36 months

Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity

Time frame: Up to 36 months

Demographic characteristics of aRCC patients as measured by continuous statistics: Height

Time frame: Up to 36 months

Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status

Time frame: Up to 36 months

Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC

Time frame: Up to 36 months

Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)

Time frame: Up to 36 months

Sequence of therapy events including treatment modalities

Time frame: Up to 36 months

Data from ClinicalTrials.gov

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