Participant Reported Outcomes and Treatment Experiences in Kidney Cancer

NCT04472663 | Completed

• 1 other identifier: CA209-7DK
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Up to 36 months

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

  Up to 36 months

Secondary Outcomes (17)

• 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

Study Arms (2)

Cohort 1

Retrospective Long-term Chart Review

Cohort 2

Prospective-Retrospective Chart Review and Humanistic Burden

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Morristown, New Jersey, 07960, United States

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 15, 2020
• Study Start: July 6, 2020
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: April 26, 2022

Record last verified: 2022-01

Locations

US (1)