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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Retrospective Long-term Chart Review | ||
| Cohort 2 | Prospective-Retrospective Chart Review and Humanistic Burden |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Cohort 1
Cohort 2:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Morristown | New Jersey | 07960 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |