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

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: Recruiting
• Conditions: Metastatic Renal Cell Carcinoma

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 (Estimated): 800

Contacts and Locations

• Study Contact: Name: Kimberly Ward; Phone Number: +19196606409; Email: kimberly.t.ward@duke.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • State University of Iowa
      • Principal Investigator: Yousef Zakharia, MD
      • Contact: Francesca Nugent
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Jane Ledesma
      • Principal Investigator: Elizabeth M Wulff-Burchfield, MD
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • The Johns Hopkins University
      • Contact: Ardit Feinaj
      • Principal Investigator: Yasser Ged, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • The Regents of the University of Michigan
      • Principal Investigator: Ajjai Alva, MD
      • Contact: Ishita Narula
      • Contact: Yue Cheng
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Noah Uhlenkamp
      • Principal Investigator: Brian Costello, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Principal Investigator: Michael Harrison, MD
      • Contact: Brea Whittenton
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Recruiting
      • Geisinger Clinic
      • Contact: Penny Gingrich
      • Principal Investigator: Sorab Gupta, MD
    • Pittsburgh, Pennsylvania, United States, 15260
      • Recruiting
      • University of Pittsburgh
      • Contact: Jeremy Stromoski
      • Principal Investigator: Risa L Wong, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • The University Of Texas Southwestern Medical Center
      • Contact: Charles-Michael Uzuegbunam
      • Principal Investigator: Tian Zhang, MD
      • Contact: Amy Rowell
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Heather Anderson
      • Principal Investigator: Benjamin Maughan, MD, PharmD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • The Medical College of Wisconsin, Inc.
      • Contact: Kailie Rothe
      • Principal Investigator: Deepak Kilari, MD

Participation Criteria

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 (≤) 6 weeks of first-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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with metastatic renal cell cancer (mRCC) with no prior systemic therapy for mRCC; This is an observational cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medication adherence as measured by patient report.	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	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	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	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	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)	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)	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)	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	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	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	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	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	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	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)	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	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

• 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 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): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: mRCC; PRO; Metastatic Renal Cell Carcinoma; RCC; ODYSSEY
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• 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