Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Duke University

Collaborating Sponsors:

Duke Clinical Research Institute

Bristol-Myers Squibb

Conditions:

Metastatic Renal Cell Carcinoma

Eligibility:

All Genders

19+ years

Brief 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 th...

Detailed 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...

Eligibility Criteria

Inclusion

  • Age 19 or over at time of informed consent.
  • 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.
  • Prior surgery and radiation therapy are permitted.
  • Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted.
  • 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

  • Patients being treated for metastatic solid tumors other than mRCC are excluded. Non-cytotoxic oral agents for adjuvant or maintenance therapy of other cancers are permitted.
  • Patients who are not intending to undergo follow up care at a study site within PCORnet

Key Trial Info

Start Date :

April 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 1 2026

Estimated Enrollment :

468 Patients enrolled

Trial Details

Trial ID

NCT04919122

Start Date

April 1 2022

End Date

July 1 2026

Last Update

August 19 2025

Active Locations (14)

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Page 1 of 4 (14 locations)

1

State University of Iowa

Iowa City, Iowa, United States, 52242

2

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

3

Ochsner Clinic Foundation d/b/a Ochsner Health

New Orleans, Louisiana, United States, 70121

4

The Johns Hopkins University

Baltimore, Maryland, United States, 21205