Metastatic Renal Cell CarcinomaODYSSEY RCCNCT04919122
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
An observational study of Metastatic Renal Cell Carcinoma, run by Duke University at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- How many people
- 468 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Apr 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
The Regents of the University of Michigan
Ann Arbor, Michigan, 48109
The Johns Hopkins University
Baltimore, Maryland, 21205
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
The Ohio State University
Columbus, Ohio, 43210
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Geisinger Clinic
Danville, Pennsylvania, 17822
Duke University
Durham, North Carolina, 27710
State University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
Ochsner Clinic Foundation d/b/a Ochsner Health
New Orleans, Louisiana, 70121
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- ODYSSEY, mRCC, Metastatic Renal Cell Carcinoma, RCC, PRO
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence as measured by patient report.
Patient's report their medication at each study visit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, every 3 months for 2 years, every 6 months for up to 36 months
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Bristol-Myers Squibb, Exelixis, Merck Sharp & Dohme LLC, Pfizer
- Responsible party
- Sponsor
- Investigators
- Daniel George, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919122
- Sponsor's protocol ID
- Pro00107408
- Acronym
- ODYSSEY RCC
- Status last verified
- Aug 2026
- First submitted
- 24 May 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhavsar NA, Harrison MR, Scales CD, Zhang T, Troy J, Ward K, Jabusch SM, Lampron Z, George DJ. Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma. Eur Urol Open Sci. 2024 Jul 3;66:75-81. doi: 10.1016/j.euros.2024.06.007. eCollection 2024 Aug.
PubMed 39070100Ged Y, Markowski MC, Singla N, Rowe SP. The shifting treatment paradigm of metastatic renal cell carcinoma. Nat Rev Urol. 2022 Nov;19(11):631-632. doi: 10.1038/s41585-022-00651-9.
PubMed 36064785
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
- ClinicalTrials.gov ID
- NCT04919122
- Acronym / sponsor ID
- ODYSSEY RCC / Pro00107408
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- ODYSSEY, mRCC, Metastatic Renal Cell Carcinoma, RCC, PRO
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Bristol-Myers Squibb, Exelixis, Merck Sharp & Dohme LLC, Pfizer
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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.
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
11 secondary outcomes
First line management choice(s)
Time frame: Up to 36 months
Subsequent line management choice(s)
Time frame: Up to 36 months
Dosing (starting dose, dose intensity, ending dose)
Time frame: Up to 36 months
Dose holds and dose interruptions
Time frame: Up to 36 months
Time on treatment
Time frame: Up to 36 months
Time to next treatment
Time frame: Up to 36 months
Early discontinuation of one agent of a combination
Time frame: Up to 36 months
Concomitant glucocorticoid use
Time frame: Up to 36 months
Work Productivity and Activity Impairment (WAPI) questionnaire
Time frame: Up to 36 months
Health care resource utilization (including hospitalizations)
Time frame: Up to 36 months
Overall survival (OS) of mRCC patients
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 39070100Bhavsar NA, Harrison MR, Scales CD, Zhang T, Troy J, Ward K, Jabusch SM, Lampron Z, George DJ. Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma. Eur Urol Open Sci. 2024 Jul 3;66:75-81. doi: 10.1016/j.euros.2024.06.007. eCollection 2024 Aug.
- Derived from this study: PubMed 36064785Ged Y, Markowski MC, Singla N, Rowe SP. The shifting treatment paradigm of metastatic renal cell carcinoma. Nat Rev Urol. 2022 Nov;19(11):631-632. doi: 10.1038/s41585-022-00651-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel George, MD principal investigator
Duke University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Duke University at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.