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ArticleEuropean urology open science2024

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.

Nrupen A Bhavsar, Michael R Harrison, Charles D Scales, Tian Zhang, Jesse Troy, Kimberly Ward, Sarah M Jabusch, Zachary Lampron, Daniel J George

Registry-linked trialAbstract read
In one paragraph

Article in European urology open science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04919122 (Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04919122 active not recruitingnot on this map

Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma (ODYSSEY RCC)

TypeobservationalSponsorDuke UniversityRan2022 to 2026Enrolled468ConditionsMetastatic Renal Cell Carcinoma
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Nrupen A BhavsarDepartment of Surgery, Duke University Health System, Durham, NC, USA.
Michael R HarrisonDuke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC, USA.
Charles D ScalesDivision of Urology, Duke University Health System, Durham, NC, USA.
Tian ZhangHarold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA.
Jesse TroyDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
Kimberly WardDuke Clinical Research Institute, Durham, NC, USA.
Sarah M JabuschDuke Clinical Research Institute, Durham, NC, USA.
Zachary LampronDuke Clinical Research Institute, Durham, NC, USA.
Daniel J GeorgeDuke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction and hypotheses: The Outcomes Database to prospectivelY aSSEss the changing TherapY landscape in Renal Cell Carcinoma (ODYSSEY RCC) Registry is a large, nationally representative prospective registry of patients with metastatic renal cell carcinoma (mRCC) that aims to provide a real-world picture of longitudinal clinical management and patient experiences that impact clinical outcomes. The primary goal of this 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 USA. Design: This is an observational, phase 4 study with planned enrollment of up to 800 patients aged ≥19 yr with mRCC in the USA. Patients will be identified through electronic health record (EHR) data from the PCORnet network of sites for care received at collaborating sites. A unique aspect of the study is the multiple data sources that will be linked to the EHR data. These include: (1) Medicare claims data, (2) laboratory results, (3) tissue specimens, (4) radiographic images, and (5) patient-reported outcomes, physicians' treatment selection, and discontinuation surveys. Protocol overview: We created a novel data resource that can inform patient care. Investigators have the opportunity to use these to study novel research questions after submitting an ancillary proposal and upon approval of the executive committee. Limitations include the potential for selection bias, residual confounding, and missing information. Summary: The ODYSSEY Registry will provide an advanced data resource that can examine numerous clinical questions related to patient and physician choice, and support methodological research related to omics and artificial intelligence. Patient summary: Cancer medications and treatments are changing rapidly. Collecting data on real-world clinical practice and patient-answered questionnaires will help us better understand cancer management and health-related quality of life while receiving metastatic renal cell carcinoma-specific treatment.

Indexed as

Health-related quality of lifeMetastatic renal cell carcinomaRenal cell carcinoma

Identifiers

PMID39070100
PMCPMC11278923

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.