Umbrella Study for Analysis of Data Related to Patients With Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06018753

Acronym

Polaris

Enrollment

Registered

2023-08-31

Start date

2023-12-06

Completion date

2025-07-01

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Data Analysis, Master Protocol, Oncology, Retrospective

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Inclusion criteria

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

Exclusion criteria

\- None

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

STUDY_DIRECTORVirginia Rhodes, MD

Tempus AI, Inc.

Outcome results