Clinical trial NCT04472663: Participant Reported Outcomes and Treatment Experiences in Kidney Cancer
Official title: Patient Reported Outcomes And Treatment Experiences In Renal Cell Carcinoma (ONE-RCC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be included if they have primary diagnosis of aRCC, age ≥18 years, with medical history available from date of aRCC diagnosis to most recent or current therapy. For Cohort 1, patients will be eligible if they had initiated 1LOT between April 2018 - March 2020. For Cohort 2, patients will be eligible if they are about to initiate 1LOT, must be willing to sign the informed consent form (ICF), where required, and complete the humanistic burden assessment at baseline and subsequent follow-ups.

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.


Eligibility 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 36 months
measure: Disease-related symptoms as measured by change from baseline in FKSI-DRS
timeFrame: Up to 36 months
Secondary outcomes:
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Age
timeFrame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by categorical statistics: Gender
timeFrame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity
timeFrame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Height
timeFrame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status
timeFrame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC
timeFrame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)
timeFrame: Up to 36 months
measure: Sequence of therapy events including treatment modalities
timeFrame: Up to 36 months
measure: Time to therapy initiation of LOT
timeFrame: Up to 36 months
measure: Rationale for therapy selection
timeFrame: Up to 36 months
measure: Switching and/or discontinuation rate
timeFrame: Up to 36 months
measure: Drug use characteristics including dosing regimens: Drugs included in each course of therapy
timeFrame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Formulations
timeFrame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Dose
timeFrame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Frequency of administration
timeFrame: Up to 36 months
measure: Drug use characteristics including dosing regimens: Duration of therapy
timeFrame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Number of cycles planned and administered
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: