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

Sponsor

Tempus Labs (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06018753

Collaborator

(none)

10,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Umbrella Study for Analysis of Data Related to Patients With Cancer

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Patients with cancer No intervention or sample collection is required on the study.

Outcome Measures

Primary Outcome Measures

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 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 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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tempus Labs

Investigators

Study Director: Anjali Avadhani, MD, Tempus Labs, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tempus Labs

ClinicalTrials.gov Identifier:

NCT06018753

Other Study ID Numbers:

TP-CA-005
Pro00073040

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tempus Labs

Study Results

No Results Posted as of Aug 31, 2023