Understanding treatment and quality of life in metastatic renal cell carcinoma patients
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
This study looks at how people with advanced kidney cancer are treated and how their quality of life changes during treatment in real-world settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Iowa City, Iowa and 10 other locations) |
| Trial ID | NCT04919122 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the management and health-related quality of life in patients with metastatic renal cell carcinoma (mRCC) in real-world clinical settings across the United States. It will collect patient-reported outcomes and evaluate treatment patterns, including first-line therapy selection and the reasons behind physician choices. Patients will undergo a baseline assessment and will be followed up through standard care visits and phone interviews to gather additional data on their experiences and outcomes. The study seeks to identify changes in quality of life and symptom burden associated with mRCC therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 or older diagnosed with mRCC who have recently started first-line or second-line systemic therapy.
Not a fit: Patients being treated for metastatic solid tumors other than mRCC will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of treatments for mRCC and improve patient care strategies.
How similar studies have performed: Other studies have shown success in assessing patient-reported outcomes in cancer treatment, indicating that this approach is both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion 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 (≤) 3 months of first-line systemic therapy or less than or equal to (≤) 3 months of second-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
Where this trial is running
Iowa City, Iowa and 10 other locations
- State University of Iowa — Iowa City, Iowa, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- The Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- The Regents of the University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Geisinger Clinic — Danville, Pennsylvania, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- The Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Daniel George, MD — Duke University
- Study coordinator: Kimberly Ward
- Email: kimberly.t.ward@duke.edu
- Phone: +19196606409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.