Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)

February 9, 2026 updated by: Duke University

Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)

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.

Study Overview

Status

Active, not recruiting

Conditions

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 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.

Study Type

Observational

Enrollment (Actual)

468

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • State University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation d/b/a Ochsner Health
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • The Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The Regents of the University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • The Medical College of Wisconsin, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with metastatic renal cell cancer (mRCC) will be identified and undergo consent and baseline assessments, including research blood collection and processing. Patient reported outcomes will be collected at baseline (pre-treatment) every 3 months for 2 years, and then every 6 months until end of follow up (with a minimum follow-up of 18 months and a maximum follow-up period of 36 months; additional follow up will be obtained based on continuous funding).

Description

Inclusion Criteria:

  • 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.

    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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in medication adherence as measured by patient report.
Time Frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
Patient's report their medication at each study visit.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in quality of life in mRCC patients receiving therapy as measured by FKSI-19
Time Frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in symptom burden in mRCC patients receiving therapy as measured by FKSI-19
Time Frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
The FKSI-19 is a questionnaire about the disease-related symptoms - physical, disease-related symptoms - emotional, treatment side-effects, and function/well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in quality of life in mRCC patients receiving therapy as measured by FACT-G
Time Frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months
Change in symptom burden in mRCC patients receiving therapy as measured by FACT-G
Time Frame: baseline, every 3 months for 2 years, every 6 months for up to 36 months
The FACT-G is a questionnaire about the physical well-being, social/family well-being, emotional well-being, and functional well-being.
baseline, every 3 months for 2 years, every 6 months for up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First line management choice(s)
Time Frame: Up to 36 months
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on line management choice(s).
Up to 36 months
Subsequent line management choice(s)
Time Frame: Up to 36 months
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on line management choice(s).
Up to 36 months
Dosing (starting dose, dose intensity, ending dose)
Time Frame: Up to 36 months
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on dosing.
Up to 36 months
Dose holds and dose interruptions
Time Frame: Up to 36 months
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on dosing holds and interruptions.
Up to 36 months
Time on treatment
Time Frame: Up to 36 months
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on time on treatment.
Up to 36 months
Time to next treatment
Time Frame: Up to 36 months
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on time to next treatment.
Up to 36 months
Early discontinuation of one agent of a combination
Time Frame: Up to 36 months
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on early discontinuation of one agent of a combination.
Up to 36 months
Concomitant glucocorticoid use
Time Frame: Up to 36 months
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on concomitant glucocorticoid use.
Up to 36 months
Work Productivity and Activity Impairment (WAPI) questionnaire
Time Frame: Up to 36 months
A composite of REDCap data entry by sites, PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on the WAPI questionnaire.
Up to 36 months
Health care resource utilization (including hospitalizations)
Time Frame: Up to 36 months
A composite of PCORnet data pull, Medicare data pull, Physician questionnaire and patient follow-up interviews will be used to get data on health care resource utilization.
Up to 36 months
Overall survival (OS) of mRCC patients
Time Frame: Up to 36 months
A composite of various starting points (time of diagnosis of metastatic disease, time of study entry and time of starting systemic therapy) to avoid lead-time bias.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Bristol-Myers Squibb
Merck Sharp & Dohme LLC
Pfizer
Duke Clinical Research Institute
Exelixis

Investigators

  • Principal Investigator: Daniel George, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00107408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Renal Cell Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe