NCT06018753

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Dec 2023Dec 2028

First Submitted

Initial submission to the registry

August 15, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

August 15, 2023

Last Update Submit

March 27, 2026

Conditions

Cancer

Keywords

Data AnalysisMaster ProtocolOncologyRetrospective

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Patients with cancer

No intervention or sample collection is required on the study.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of subjects targeted are: 1) those who have cancer, and 2) those for whom medical records are available.

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Memorial Health Services

Fountain Valley, California, 98708, United States

Location

Cancer Specialists of Northern Florida

Jacksonville, Florida, 32256, United States

Location

Hawaii Cancer Care

Honolulu, Hawaii, 96813, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

Northwest Oncology and Hematology

Rolling Meadows, Illinois, 60008, United States

Location

Community Health Network

Indianapolis, Indiana, 46256, United States

Location

Southcoast Centers for Cancer Care

Fairhaven, Massachusetts, 02719, United States

Location

Sanford Fargo

Fargo, North Dakota, 58102, United States

Location

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (4)

  • 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/

    BACKGROUND

  • 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

    BACKGROUND

  • 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/

    BACKGROUND

  • 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.

    PMID: 32011317BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Virginia Rhodes, MD

    Tempus AI, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 31, 2023

Study Start

December 6, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

US(10)