Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT04472663
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-15
• Primary Completion: 2020-12-09
• Study Completion: 2020-12-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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: Family history of RCC	Up to 36 months
Time to therapy initiation of LOT	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: Age	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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Morristown, New Jersey, United States