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

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ClinicalTrials.gov Identifier: NCT04919122
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : October 14, 2022
Sponsor:
Collaborators:
Duke Clinical Research Institute
Bristol-Myers Squibb
Exelixis
Merck Sharp & Dohme LLC
Pfizer
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026


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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Biospecimen Retention:   Samples With DNA
36.5 mL of blood will be taken at their enrollment visit or collected up to 6 weeks after enrollment or until first line therapy begins.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

Inclusion Criteria:

  • Age 19 or over at time of informed consent.
  • Diagnosis of metastatic renal cell cancer (mRCC) with no prior 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 active malignancies other than mRCC are excluded, unless all systemic therapy was completed at least 3 months prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919122


Contacts
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Contact: Kimberly Ward +19196606409 kimberly.t.ward@duke.edu

Locations
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United States, Iowa
State University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Francesca Nugent         
Principal Investigator: Yousef Zakharia, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jane Ledesma         
Principal Investigator: Elizabeth M Wulff-Burchfield, MD         
United States, Maryland
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Ardit Feinaj         
Principal Investigator: Yasser Ged, MD         
United States, Michigan
The Regents of the University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alicia Ali         
Principal Investigator: Ajjai Alva, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Kobhe Macias         
Principal Investigator: Michael Harrison, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Cathy Cochran         
Principal Investigator: Risa L Wong, MD         
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Amy Rowell         
Principal Investigator: Tian Zhang, MD         
United States, Wisconsin
The Medical College of Wisconsin, Inc. Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Kelly Ertl         
Principal Investigator: Deepak Kilari, MD         
Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
Bristol-Myers Squibb
Exelixis
Merck Sharp & Dohme LLC
Pfizer
Investigators
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Principal Investigator: Daniel George, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04919122    
Other Study ID Numbers: Pro00107408
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
ODYSSEY
mRCC
Metastatic Renal Cell Carcinoma
RCC
PRO
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases