Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma

Launched by DUKE UNIVERSITY · Jun 2, 2021

Keywords

ClinConnect Summary

The ODYSSEY RCC trial is a study designed to learn more about how metastatic renal cell carcinoma (mRCC) is being treated in real-world settings across the United States. Researchers want to understand how these treatments affect the quality of life for patients. This study is open to patients aged 19 and older who have just started their first treatment for mRCC, whether that’s through surgery, radiation, or other therapies. It’s important that participants can complete surveys about their health and experiences during the study.

If you decide to join the trial, you will be closely monitored as part of your regular care at a clinic. The study is currently recruiting participants, and it is open to all genders. However, if you are being treated for other types of cancer, you may not be eligible. Overall, this trial aims to gather valuable information that can help improve treatment and care for people with metastatic renal cell carcinoma.

Gender

ALL

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 (≤) 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