Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-001462
NCT ID: NCT04919122
Sponsor Protocol Number: Pro00107408
About this study
The purpose of this study is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 7/19/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Brian Costello, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available