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OpenTrials
Completed

NCT Number: NCT04472663

Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

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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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Morristown, New Jersey, 07960, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 36 months

  2. Disease-related symptoms as measured by change from baseline in FKSI-DRS

    Time frame: Up to 36 months

Secondary outcomes

  1. Demographic characteristics of aRCC patients as measured by continuous statistics: Age

    Time frame: Up to 36 months

  2. Demographic characteristics of aRCC patients as measured by categorical statistics: Gender

    Time frame: Up to 36 months

  3. Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity

    Time frame: Up to 36 months

  4. Demographic characteristics of aRCC patients as measured by continuous statistics: Height

    Time frame: Up to 36 months

  5. Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status

    Time frame: Up to 36 months

  6. Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC

    Time frame: Up to 36 months

  7. Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)

    Time frame: Up to 36 months

  8. Sequence of therapy events including treatment modalities

    Time frame: Up to 36 months

  9. Time to therapy initiation of LOT

    Time frame: Up to 36 months

  10. Rationale for therapy selection

    Time frame: Up to 36 months

  11. Switching and/or discontinuation rate

    Time frame: Up to 36 months

  12. Drug use characteristics including dosing regimens: Drugs included in each course of therapy

    Time frame: Up to 36 months

  13. Drug use characteristics including dosing regimens : Formulations

    Time frame: Up to 36 months

  14. Drug use characteristics including dosing regimens : Dose

    Time frame: Up to 36 months

  15. Drug use characteristics including dosing regimens : Frequency of administration

    Time frame: Up to 36 months

  16. Drug use characteristics including dosing regimens: Duration of therapy

    Time frame: Up to 36 months

  17. Drug use characteristics including dosing regimens : Number of cycles planned and administered

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2020
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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