Clinical trial NCT06207032: TEMPUS ARIES: A Biobank Registry Platform Study in Oncology
Official title: TEMPUS ARIES: A Biobank Registry Platform Study in Oncology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: ctDNA
Next-Generation Sequencing
Oncology
Lead sponsor: Tempus AI
Sponsor class: INDUSTRY
First posted: 2024-01-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with cancer willing to have additional blood samples collected for ctDNA research.

Brief summary: This study is a non-interventional, multicenter, multicohort evaluation of participants with cancer who will undergo longitudinal plasma ctDNA biomarker profiling at specific time points in addition to standard of care therapy.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age
2. Willing to participate in the research
3. Able to provide informed consent
4. Must be diagnosed with cancer

Exclusion Criteria:

1. Not willing or able to have additional blood samples collected

Primary outcomes:
measure: Changes in ctDNA from baseline, on-treatment and post-treatment blood samples.
timeFrame: 5 years
Secondary outcomes:
measure: Generation of DNA, RNA, immune and other multiomic datasets.
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Whittier
country: United States
facility: PIH Health Whittier Hospital & PIH Health Physicians
state: California
city: Norwich
country: United States
facility: Eastern CT and Hematology and Oncology Associates
state: Connecticut
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Atlanta
country: United States
facility: Morehouse
state: Georgia
city: Carterville
country: United States
facility: Southern Illinois Healthcare
state: Illinois
city: Hinsdale
country: United States
facility: Hope and Healing Cancer Services
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Specialists of Illinois
state: Illinois
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: Fort Wayne
country: United States
facility: Fort Wayne
state: Indiana
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Morehead
country: United States
facility: St. Claire Healthcare
state: Kentucky
city: Frederick
country: United States
facility: Frederick Health Regional System
state: Maryland
city: Fairhaven
country: United States
facility: Southcoast Centers for Cancer Care
state: Massachusetts
city: Hannibal
country: United States
facility: Hannibal Regional Healthcare System, Inc.
state: Missouri
city: Osage Beach
country: United States
facility: Lake Regional Health
state: Missouri
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Las Vegas
country: United States
facility: Hope Cancer Care of Nevada
state: Nevada
city: Reno
country: United States
facility: Cancer Care Specialists - Reno
state: Nevada
city: Belleville
country: United States
facility: New Jersey Cancer Center
state: New Jersey
city: Belleville
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central NY
state: New York
city: Ithaca
country: United States
facility: Cayuga Medical Center
state: New York
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center (Fargo)
state: North Dakota
city: Maumee
country: United States
facility: Taylor Cancer Research Center
state: Ohio
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials
Study officials:
affiliation: Tempus AI, Inc.
name: Michelle Ting-Lin, 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: Abbosh C, Birkbak NJ, Swanton C. Early stage NSCLC - challenges to implementing ctDNA-based screening and MRD detection. Nat Rev Clin Oncol. 2018 Sep;15(9):577-586. doi: 10.1038/s41571-018-0058-3.
citation: Vellanki PJ, Ghosh S, Pathak A, Fusco MJ, Bloomquist EW, Tang S, Singh H, Philip R, Pazdur R, Beaver JA. Regulatory implications of ctDNA in immuno-oncology for solid tumors. J Immunother Cancer. 2023 Feb;11(2):e005344. doi: 10.1136/jitc-2022-005344.
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: Use of circulating tumor deoxyribonucleic acid for early-stage solid tumor drug development; Draft guidance for industry. Accessed September 8, 2023. https://www.fda.gov/media/158072/
citation: Beaubier N, Tell R, Lau D, Parsons JR, Bush S, Perera J, Sorrells S, Baker T, Chang A, Michuda J, Iguartua C, MacNeil S, Shah K, Ellis P, Yeatts K, Mahon B, Taxter T, Bontrager M, Khan A, Huether R, Lefkofsky E, White KP. Clinical validation of the tempus xT next-generation targeted oncology sequencing assay. Oncotarget. 2019 Mar 22;10(24):2384-2396. doi: 10.18632/oncotarget.26797. eCollection 2019 Mar 22.
citation: Beaubier N, Bontrager M, Huether R, Igartua C, Lau D, Tell R, Bobe AM, Bush S, Chang AL, Hoskinson DC, Khan AA, Kudalkar E, Leibowitz BD, Lozachmeur A, Michuda J, Parsons J, Perera JF, Salahudeen A, Shah KP, Taxter T, Zhu W, White KP. Integrated genomic profiling expands clinical options for patients with cancer. Nat Biotechnol. 2019 Nov;37(11):1351-1360. doi: 10.1038/s41587-019-0259-z. Epub 2019 Sep 30.
citation: Finkle JD, Boulos H, Driessen TM, Lo C, Blidner RA, Hafez A, Khan AA, Lozac'hmeur A, McKinnon KE, Perera J, Zhu W, Dowlati A, White KP, Tell R, Beaubier N. Validation of a liquid biopsy assay with molecular and clinical profiling of circulating tumor DNA. NPJ Precis Oncol. 2021 Jul 2;5(1):63. doi: 10.1038/s41698-021-00202-2.