Kidney Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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.

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 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 is for people with:

Kidney Cancer

Estimated Enrollment:

800

Study ID:

NCT04919122

Recruitment Status:

Recruiting

Sponsor:

Duke University

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There are 11 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Estimated Enrollment:

800

Study ID:

NCT04919122

Recruitment Status:

Recruiting

Sponsor:


Duke University

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