Umbrella Study for Analysis of Data Related to Patients With Cancer

Cancer Clinical Trial

— Polaris  

Official title:

Umbrella Study for Analysis of Data Related to Patients With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018753
• Other study ID #: TP-CA-005
• Secondary ID: Pro00073040
• Status: Recruiting
• Start date: December 6, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: May 2024
• Source: Tempus AI
• Contact: Lauren Lopez
• Phone: tel:8007394137
• Email: polaris[@]tempus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 1, 2028
• Est. primary completion date: September 1, 2028
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	Hawaii Cancer Care	Honolulu	Hawaii
United States	Community Health Network	Indianapolis	Indiana
United States	MemorialCare	Long Beach	California
United States	Illinois Cancer Care	Peoria	Illinois
United States	Avera Cancer Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Tempus AI

Country where clinical trial is conducted

United States, 

References & Publications (4)

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/

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

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. — View Citation

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/

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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