Umbrella Study for Analysis of Data Related to Patients With Cancer

Recruiting

• Conditions: Cancer

• Registration Number: NCT06018753
• Lead Sponsor: Tempus AI

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-08-31
• Study Start: 2023-12-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2028-09-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Provide RWD/E Datasets to Research Collaborators to Support Commercialization	5 years	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.
Provide RWD/E Datasets to Research Collaborators to Support Development	5 years	Use data analysis to enable deeper understanding of patient population characteristics and outcomes to more accurately assess clinical trial feasibility and optimize trial design.
Provide RWD/E Datasets to Research Collaborators to Support Real-World Insights	5 years	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.
Provide RWD/E Datasets to Research Collaborators to Support Regulatory	5 years	Use data analysis to generate supplemental data for new accelerated approval pathway filings and provide real world control arms where necessary.
Provide RWD/E Datasets to Research Collaborators to Support Phase IV Surveillance	5 years	Use data analysis to support post approval understanding of longer term side effects that may not be sufficiently detected via randomized clinical trials.

Trial Locations

Locations (10)

Illinois Cancer Care; 🇺🇸 Peoria, Illinois, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Cancer Specialists of Northern Florida; 🇺🇸 Jacksonville, Florida, United States

Hawaii Cancer Care; 🇺🇸 Honolulu, Hawaii, United States

Northwest Oncology and Hematology; 🇺🇸 Rolling Meadows, Illinois, United States

Taylor Cancer Research Center; 🇺🇸 Maumee, Ohio, United States

Memorial Health Services; 🇺🇸 Fountain Valley, California, United States

Community Health Network; 🇺🇸 Indianapolis, Indiana, United States

Southcoast Centers for Cancer Care; 🇺🇸 Fairhaven, Massachusetts, United States

Sanford Fargo; 🇺🇸 Fargo, North Dakota, United States