Outcomes Database to Prospectively Assess Changing Therapy Landscape in Renal Cell Carcinoma (ODYSSEY RCC)

Page last updated May 11, 2026

ClinicalTrials.gov#: NCT04919122
Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: Dan George
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Industry (Exelixis, Bristol Myers Squibb, Merck, Pfizer)
Funding Date: 2020
Study Duration: 2022 – 2026
Participating PCORnet® Clinical Research Networks: GPC, PaTH, REACHnet, STAR
Therapeutic Area: Oncology
Condition: Metastatic Renal Cell Carcinoma
Age Range: 19 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. Can a research registry of patients with metastatic renal cell carcinoma (mRCC) patients help us better understand cancer management and health-related quality of life while receiving mRCC specific treatment? In combination with patient and physician surveys, PCORnet will be used to help us answer these questions.

Primary Publication(s):

Bhavsar NA, Harrison MR, Scales CD, et al. Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma. Eur Urol Open Sci. 2024;66:75-81. Published 2024 Jul 3. doi:10.1016/j.euros.2024.06.007

ACTIV-6: COVID-19 Study of Repurposed Medications

Page last updated May 11, 2026

ClinicalTrials.gov#: NCT04885530
Study Design: Intervention Trial
PCORnet Infrastructure: Single IRB, Patient partners or engagement
Principal Investigator: Adrian Hernandez
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Federal (NIH)
Funding Date: 2021
Study Duration: 2021 – 2025
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition
: COVID-19
Age Range: 30 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):
Can repurposed medications reduce symptoms of non-hospitalized participants with mild to moderate COVID-19?

Primary Publication(s):

Naggie SBoulware DRLindsell CJ, et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19A Randomized Clinical TrialJAMA. 2022;328(16):1595–1603. doi:10.1001/jama.2022.18590

McCarthy MW, Naggie S, Boulware DR, et al. Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(4):296–305. doi:10.1001/jama.2022.24100

Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(11):888–897. doi:10.1001/jama.2023.1650

Biologic Abatement and Capturing Kids’ Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

Page last updated May 11, 2026

Study Website: The BACK-OFF JSpA Study
ClinicalTrials.gov#: NCT04891640
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Pamela F. Weiss
Institution: The Children's Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2020
Study Duration: 2021 – 2026
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Autoimmune (Allergy & Immunology), Spondyloarthritis
Condition: Juvenile Spondyloarthritis
Age Range: 8 Years to 21 Years (Child,  Adult)
Status: Active, not recruiting

Research Question(s):

This trial will compare how patients with inactive spondyloarthritis on tumor necrosis factor inhibitor (TNFi) treatment respond to three treatment options that doctors currently use:

  • Continue standard TNFi medication,
  • Space out the time between usual TNFi medication doses, or
  • Stop the TNFi medication. If we can safely prolong the time between doses or completely take away TNFi therapy in this population, we may remove unnecessary medication exposure, improve patient quality of life, and lower medication costs.