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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 : April 17, 2024
Sponsor:
Collaborators:
Duke Clinical Research Institute
Bristol-Myers Squibb
Exelixis
Merck Sharp & Dohme LLC
Pfizer
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date May 24, 2021
First Posted Date June 9, 2021
Last Update Posted Date April 17, 2024
Actual Study Start Date April 1, 2022
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2022)
  • 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.
Original Primary Outcome Measures
 (submitted: June 2, 2021)
  • 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 ]
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: June 2, 2021)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
Official Title Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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).
Condition Metastatic Renal Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts Patients with metastatic renal cell cancer (mRCC) with no prior systemic therapy for mRCC
This is an observational cohort.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 2, 2021)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2026
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
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.

    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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kimberly Ward +19196606409 kimberly.t.ward@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04919122
Other Study ID Numbers Pro00107408
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor Duke University
Original Study Sponsor Same as current
Collaborators
  • Duke Clinical Research Institute
  • Bristol-Myers Squibb
  • Exelixis
  • Merck Sharp & Dohme LLC
  • Pfizer
Investigators
Principal Investigator: Daniel George, MD Duke University
PRS Account Duke University
Verification Date April 2024