Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
NCT ID: NCT04919122
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
468 participants
OBSERVATIONAL
2022-04-01
2026-12-31
Brief Summary
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Detailed Description
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The primary objective is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy.
Patients will be identified and undergo consent and baseline assessments, including research blood collection and processing, by the study site team, this baseline visit will be their only clinic visits per protocol. All other visits are standard of care visits and outside the scope of the study.
Subsequent follow up with be coordinated centrally by DCRI. Additional clinic data will be obtained via PCORnet data pull and Medicare claims. Patient reported outcomes, quality of life and medications data will be obtained via the DCRI Call Center through follow-up phone interviews.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with mRCC with ≤ 3 mos of 1L or 2L systemic therapy
This is an observational cohort.
* mRCC = metastatic renal cell cancer
* 1L=first-line systemic therapy
* 2L=second-line systemic therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of metastatic renal cell cancer (mRCC) with less than or equal to (≤) 3 months of first-line systemic therapy or less than or equal to (≤) 3 months of second-line systemic therapy for mRCC.
1. Prior surgery and radiation therapy are permitted.
2. Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted.
3. Patients currently not on therapy and being observed are permitted.
* Evidence of signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
* Ability to comply with completion of PROs
Exclusion Criteria
* Patients who are not intending to undergo follow up care at a study site within PCORnet
19 Years
ALL
No
Sponsors
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Duke Clinical Research Institute
OTHER
Bristol-Myers Squibb
INDUSTRY
Exelixis
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Pfizer
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Daniel George, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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State University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Clinic Foundation d/b/a Ochsner Health
New Orleans, Louisiana, United States
The Johns Hopkins University
Baltimore, Maryland, United States
The Regents of the University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Geisinger Clinic
Danville, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Countries
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References
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Bhavsar NA, Harrison MR, Scales CD, Zhang T, Troy J, Ward K, Jabusch SM, Lampron Z, George DJ. Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma. Eur Urol Open Sci. 2024 Jul 3;66:75-81. doi: 10.1016/j.euros.2024.06.007. eCollection 2024 Aug.
Ged Y, Markowski MC, Singla N, Rowe SP. The shifting treatment paradigm of metastatic renal cell carcinoma. Nat Rev Urol. 2022 Nov;19(11):631-632. doi: 10.1038/s41585-022-00651-9.
Other Identifiers
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Pro00107408
Identifier Type: -
Identifier Source: org_study_id
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