Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; Retrospective Long-term Chart Review
Cohort 2; Prospective-Retrospective Chart Review and Humanistic Burden

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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: Gender	Up to 36 months
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: 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: Family history of RCC	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
Time to therapy initiation of LOT	Up to 36 months
Rationale for therapy selection	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
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 : Frequency of administration	Up to 36 months
Drug use characteristics including dosing regimens: Duration of therapy	Up to 36 months
Drug use characteristics including dosing regimens : Number of cycles planned and administered	Up to 36 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: CA209-7DK