Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma

Last updated: February 9, 2026
Sponsor: Duke University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT04919122
Pro00107408
  • Ages > 19
  • All Genders

Study Summary

ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 19 or over at time of informed consent.

  • Diagnosis of metastatic renal cell cancer (mRCC) with less than or equal to (≤) 3months of first-line systemic therapy or less than or equal to (≤) 3 months ofsecond-line systemic therapy for mRCC.

  1. Prior surgery and radiation therapy are permitted.

  2. Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinomaare permitted.

  3. Patients currently not on therapy and being observed are permitted.

  • Evidence of signed and dated informed consent document indicating that the patienthas been informed of all pertinent aspects of the study.

  • Ability to comply with completion of PROs

Exclusion

Exclusion Criteria:

  • Patients being treated for metastatic solid tumors other than mRCC are excluded.Non-cytotoxic oral agents for adjuvant or maintenance therapy of other cancers arepermitted.

  • Patients who are not intending to undergo follow up care at a study site withinPCORnet

Study Design

Total Participants: 468
Study Start date:
April 01, 2022
Estimated Completion Date:
December 31, 2026

Study Description

This trial is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Primarily, the study will evaluate patient experience through collection of patient reported outcomes (PROs). The study will also collect and assess information on the therapies used such as first-line treatment selection, treatment sequence and duration, the drivers of physician selection of particular agents, and discontinuation of therapies.

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.

Connect with a study center

  • State University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • State University of Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Ochsner Clinic Foundation d/b/a Ochsner Health

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Clinic Foundation d/b/a Ochsner Health

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Site Not Available

  • The Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • The Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 21205
    United States

    Site Not Available

  • The Regents of the University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • The Regents of the University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • The University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Ohio State University

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Geisinger Clinic

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Geisinger Clinic

    Danville 5186327, Pennsylvania 6254927 17822
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15260
    United States

    Site Not Available

  • The University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • The University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • The Medical College of Wisconsin, Inc.

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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