CancerPolarisNCT06018753
Umbrella Study for Analysis of Data Related to Patients With Cancer
An observational study of Cancer, run by Tempus AI at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 77 participants
- Where
- 10 sitesUnited States
- Study dates
- 6 Dec 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The population of subjects targeted are: 1) those who have cancer, and 2) those for whom medical records are available.
Who may be able to join
- Subjects must be diagnosed with cancer
- Medical records available to meet cohort requirements
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
Sanford Fargo
Fargo, North Dakota, 58102
Memorial Health Services
Fountain Valley, California, 98708
Hawaii Cancer Care
Honolulu, Hawaii, 96813
Community Health Network
Indianapolis, Indiana, 46256
Cancer Specialists of Northern Florida
Jacksonville, Florida, 32256
Taylor Cancer Research Center
Maumee, Ohio, 43537
Illinois Cancer Care
Peoria, Illinois, 61615
Northwest Oncology and Hematology
Rolling Meadows, Illinois, 60008
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
About this study
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.
Read the 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.
- Conditions
- Cancer
- Keywords
- Data Analysis, Master Protocol, Oncology, Retrospective
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer | No intervention or sample collection is required on the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start6 Dec 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Tempus AIThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tempus AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Virginia Rhodes, MD, Study director, Tempus AI, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018753
- Sponsor's protocol ID
- TP-CA-005
- Other IDs
- Pro00073040
- Acronym
- Polaris
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32011317
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbrella Study for Analysis of Data Related to Patients With Cancer
- ClinicalTrials.gov ID
- NCT06018753
- Acronym / sponsor ID
- Polaris / TP-CA-005
- Conditions
- Cancer
- Keywords
- Data Analysis, Master Protocol, Oncology, Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Tempus AIIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer | – | –No intervention or sample collection is required on the study. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The population of subjects targeted are: 1) those who have cancer, and 2) those for whom medical records are available.
Key inclusion criteria (2 listed)
- Subjects must be diagnosed with cancer
- Medical records available to meet cohort requirements
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Provide RWD/E Datasets to Research Collaborators to Support Development
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- BackgroundThomas 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/
- BackgroundOffice 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
- BackgroundGrayson 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/
- Background: PubMed 32011317Rudrapatna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Rhodes, MD study director
Tempus AI, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Tempus AI at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provide RWD/E Datasets to Research Collaborators to Support Development (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018753, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.