Clinical trial NCT06018753: Umbrella Study for Analysis of Data Related to Patients With Cancer
Official title: Umbrella Study for Analysis of Data Related to Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Data Analysis
Master Protocol
Oncology
Retrospective
Lead sponsor: Tempus AI
Sponsor class: INDUSTRY
First posted: 2023-08-31
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of subjects targeted are: 1) those who have cancer, and 2) those for whom medical records are available.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- None

Primary outcomes:
measure: Provide RWD/E Datasets to Research Collaborators to Support Development
timeFrame: 5 years
measure: Provide RWD/E Datasets to Research Collaborators to Support Regulatory
timeFrame: 5 years
measure: Provide RWD/E Datasets to Research Collaborators to Support Commercialization
timeFrame: 5 years
measure: Provide RWD/E Datasets to Research Collaborators to Support Phase IV Surveillance
timeFrame: 5 years
measure: Provide RWD/E Datasets to Research Collaborators to Support Real-World Insights
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Memorial Health Services
state: California
city: Jacksonville
country: United States
facility: Cancer Specialists of Northern Florida
state: Florida
city: Honolulu
country: United States
facility: Hawaii Cancer Care
state: Hawaii
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Rolling Meadows
country: United States
facility: Northwest Oncology and Hematology
state: Illinois
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Fairhaven
country: United States
facility: Southcoast Centers for Cancer Care
state: Massachusetts
city: Fargo
country: United States
facility: Sanford Fargo
state: North Dakota
city: Maumee
country: United States
facility: Taylor Cancer Research Center
state: Ohio
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
Study officials:
affiliation: Tempus AI, Inc.
name: Virginia Rhodes, MD
role: STUDY_DIRECTOR
References:
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/
citation: 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
citation: 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/
citation: 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.