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

Bristol-Myers Squibb1 site in 1 country5 target enrollmentJuly 6, 2020

ConditionsKidney Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 5
Locations: 1
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2020

End Date

December 9, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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

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: Family history of RCC(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)
Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity(Up to 36 months)
Rationale for therapy selection(Up to 36 months)
Drug use characteristics including dosing regimens : Frequency of administration(Up to 36 months)
Drug use characteristics including dosing regimens : Number of cycles planned and administered(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: Healthcare coverage (medical and drug)(Up to 36 months)
Sequence of therapy events including treatment modalities(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: Duration of therapy(Up to 36 months)
Demographic characteristics of aRCC patients as measured by categorical statistics: Gender(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)