Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472663
• Other study ID #: CA209-7DK
• Status: Completed
• Start date: July 6, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Locations

Country	Name	City	State
United States	Local Institution	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		Up to 36 months
Primary	Disease-related symptoms as measured by change from baseline in FKSI-DRS		Up to 36 months
Secondary	Demographic characteristics of aRCC patients as measured by continuous statistics: Age		Up to 36 months
Secondary	Demographic characteristics of aRCC patients as measured by categorical statistics: Gender		Up to 36 months
Secondary	Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity		Up to 36 months
Secondary	Demographic characteristics of aRCC patients as measured by continuous statistics: Height		Up to 36 months
Secondary	Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status		Up to 36 months
Secondary	Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC		Up to 36 months
Secondary	Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)		Up to 36 months
Secondary	Sequence of therapy events including treatment modalities		Up to 36 months
Secondary	Time to therapy initiation of LOT		Up to 36 months
Secondary	Rationale for therapy selection		Up to 36 months
Secondary	Switching and/or discontinuation rate		Up to 36 months
Secondary	Drug use characteristics including dosing regimens: Drugs included in each course of therapy		Up to 36 months
Secondary	Drug use characteristics including dosing regimens : Formulations		Up to 36 months
Secondary	Drug use characteristics including dosing regimens : Dose		Up to 36 months
Secondary	Drug use characteristics including dosing regimens : Frequency of administration		Up to 36 months
Secondary	Drug use characteristics including dosing regimens: Duration of therapy		Up to 36 months
Secondary	Drug use characteristics including dosing regimens : Number of cycles planned and administered		Up to 36 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls