Umbrella Study for Analysis of Data Related to Patients With Cancer (Polaris)

This study is a multisite, minimal risk, non-interventional study using patient electronic health record data collected as part of standard of care to answer cohort-based research questions and create robust real-world data sets.

Study Overview

• Status: Completed
• Conditions: Cancer

Detailed Description

One key purpose of the Study is to collect data that may be used for a wide range of scientific questions and real-world insights.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 98708
      • Memorial Health Services
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of Northern Florida
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Rolling Meadows, Illinois, United States, 60008
      • Northwest Oncology and Hematology
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Community Health Network
  • Massachusetts
    • Fairhaven, Massachusetts, United States, 02719
      • Southcoast Centers for Cancer Care
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Fargo
  • Ohio
    • Maumee, Ohio, United States, 43537
      • Taylor Cancer Research Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population of subjects targeted are: 1) those who have cancer, and 2) those for whom medical records are available.

Description

Inclusion Criteria:

• Subjects must be diagnosed with cancer
• Medical records available to meet cohort requirements

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with cancer; No intervention or sample collection is required on the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provide RWD/E Datasets to Research Collaborators to Support Development	Use data analysis to enable deeper understanding of patient population characteristics and outcomes to more accurately assess clinical trial feasibility and optimize trial design.	5 years
Provide RWD/E Datasets to Research Collaborators to Support Regulatory	Use data analysis to generate supplemental data for new accelerated approval pathway filings and provide real world control arms where necessary.	5 years
Provide RWD/E Datasets to Research Collaborators to Support Commercialization	Use data analysis to enable more precise characterization of biomarker testing rates, factors influencing access to testing, and uptake of recently approved therapies to inform commercial strategy for pharmaceutical companies and generate evidence for payors.	5 years
Provide RWD/E Datasets to Research Collaborators to Support Phase IV Surveillance	Use data analysis to support post approval understanding of longer term side effects that may not be sufficiently detected via randomized clinical trials.	5 years
Provide RWD/E Datasets to Research Collaborators to Support Real-World Insights	Use data analysis to further understanding of variations in patient care across the US to help ensure patients have access to optimal testing and treatment.	5 years

Collaborators and Investigators

• Sponsor: Tempus AI
• Investigators: Study Director: Virginia Rhodes, MD, Tempus AI, Inc.

Publications and helpful links

General Publications

• Thomas M. Pharma and the benefits of Real World Data. Drug Discovery World (DDW). Published November 4, 2021. Accessed May 5, 2023. https://www.ddw-online.com/trends-analysis-pharma-and-the-benefits-of-real-world-data-13702-202111/
• Office of the Commissioner. Oncology Real World Evidence Program. U.S. Food and Drug Administration. Accessed May 5, 2023. https://www.fda.gov/about-fda/oncology-center-excellence/oncology-real-world-evidence-program
• Grayson N. Real-world data can help make better drugs and do it faster. STAT. Published May 2, 2018. Accessed May 5, 2023. https://www.statnews.com/2018/05/02/real-world-data-drug-development/
• Rudrapatna VA, Butte AJ. Opportunities and challenges in using real-world data for health care. J Clin Invest. 2020 Feb 3;130(2):565-574. doi: 10.1172/JCI129197.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Oncology; Master Protocol; Retrospective; Data Analysis
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TP-CA-005; Pro00073040 (Other Identifier: Advarra)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No