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

Metastatic Renal Cell Carcinoma Clinical Trial

— ODYSSEY RCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919122
• Other study ID #: Pro00107408
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Kimberly Ward
• Phone: +19196606409
• Email: kimberly.t.ward[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Locations

Country	Name	City	State
United States	The Regents of the University of Michigan	Ann Arbor	Michigan
United States	The Johns Hopkins University	Baltimore	Maryland
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Duke University	Durham	North Carolina
United States	State University of Iowa	Iowa City	Iowa
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	The Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah

Sponsors (6)

Lead Sponsor	Collaborator
Duke University	Bristol-Myers Squibb, Duke Clinical Research Institute, Exelixis, Merck Sharp & Dohme LLC, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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