TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

NCT06207032 | Recruiting

• 2 other identifiers: TP-CA-007Pro00076336
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 32

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.

Conditions

Cancer

Keywords

ctDNA; Next-Generation Sequencing; Oncology

Outcome Measures

Primary Outcomes (1)

• Changes in ctDNA from baseline, on-treatment and post-treatment blood samples.

  Assess ctDNA kinetics using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, and time to ctDNA recurrence and correlate with standard of care therapy real-world outcomes such as overall survival, progression-free survival, time to next treatment, and time to treatment discontinuation.

  5 years

Secondary Outcomes (1)

• Generation of DNA, RNA, immune and other multiomic datasets.

  5 years

Study Arms (7)

Cohort 001: KRAS mutated CRC

No intervention.

Cohort 002: KRAS mutated PDAC

No intervention.

Cohort 003: KRAS mutated NSCLC

No intervention.

Cohort 004: Gastric 1L Plus

No intervention.

Cohort 005: mCRPC 1L Plus

No intervention.

Cohort 006: Pan Tumor ADCs

No intervention.

Cohort 007: Stage III-IV EGFR Activating Mutation NSCLC

No intervention.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with cancer willing to have additional blood samples collected for ctDNA research.

You may qualify if:

• ≥18 years of age
• Willing to participate in the research
• Able to provide informed consent
• Must be diagnosed with cancer

You may not qualify if:

• \. Not willing or able to have additional blood samples collected

Sponsors & Collaborators

• Tempus AI: lead

Study Sites (32)

Alabama Oncology

Birmingham, Alabama, 35233, United States

RECRUITING

PIH Health Whittier Hospital & PIH Health Physicians

Whittier, California, 90605, United States

RECRUITING

Eastern CT and Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

RECRUITING

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

RECRUITING

Morehouse

Atlanta, Georgia, 30310, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30318, United States

RECRUITING

Southern Illinois Healthcare

Carterville, Illinois, 62918, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

RECRUITING

Cancer Care Specialists of Illinois

O'Fallon, Illinois, 62269, United States

RECRUITING

Illinois Cancer Care

Peoria, Illinois, 61615, United States

RECRUITING

Northwest Oncology and Hematology

Rolling Meadows, Illinois, 60008, United States

TERMINATED

Fort Wayne

Fort Wayne, Indiana, 46804, United States

TERMINATED

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

RECRUITING

St. Claire Healthcare

Morehead, Kentucky, 40351, United States

TERMINATED

Frederick Health Regional System

Frederick, Maryland, 21702, United States

RECRUITING

Southcoast Centers for Cancer Care

Fairhaven, Massachusetts, 02719, United States

RECRUITING

Hannibal Regional Healthcare System, Inc.

Hannibal, Missouri, 63401, United States

RECRUITING

Lake Regional Health

Osage Beach, Missouri, 65065, United States

RECRUITING

Mosaic Life Care

Saint Joseph, Missouri, 64506, United States

ACTIVE NOT RECRUITING

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

RECRUITING

Hope Cancer Care of Nevada

Las Vegas, Nevada, 89103, United States

TERMINATED

Cancer Care Specialists - Reno

Reno, Nevada, 89511, United States

RECRUITING

New Jersey Cancer Center

Belleville, New Jersey, 07109, United States

TERMINATED

Regional Cancer Care Associates

Belleville, New Jersey, 07109, United States

TERMINATED

Hematology Oncology Associates of Central NY

East Syracuse, New York, 13057, United States

RECRUITING

Cayuga Medical Center

Ithaca, New York, 14850, United States

RECRUITING

Sanford Roger Maris Cancer Center (Fargo)

Fargo, North Dakota, 58102, United States

RECRUITING

Aultman Medical Group

Canton, Ohio, 44710, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

RECRUITING

Cancer Care Northwest

Spokane, Washington, 99216, United States

RECRUITING

Pan American Center for Oncology Trials

Rio Piedras, Puerto Rico, 00935, Puerto Rico

RECRUITING

Related Publications (9)

• 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

• 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.

  PMID: 29968853 BACKGROUND

• 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.

  PMID: 36796877 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

• 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/

  BACKGROUND

• 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.

  PMID: 31040929 BACKGROUND

• 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.

  PMID: 31570899 BACKGROUND

• 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.

  PMID: 34215841 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected at pre-specified baseline, on-treatment and post-treatment timepoints. Left-over tissue may be collected from standard of care procedures depending on the indication.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michelle Ting-Lin, MD

  Tempus AI, Inc.

  STUDY DIRECTOR

Central Study Contacts

Lauren Lopez

CONTACT

8007394137; aries@tempus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

PR (1); US (31)