Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Kidney Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04472663

CA209-7DK

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria apply

Trial design

5 participants in 2 patient groups

Cohort 1

Description:

Retrospective Long-term Chart Review

Cohort 2

Description:

Prospective-Retrospective Chart Review and Humanistic Burden