TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

ClinicalTrials.gov ID

NCT06207032

Acronym / sponsor ID

TP-CA-007

Conditions

Cancer

Keywords

ctDNA, Next-Generation Sequencing, Oncology

Study type

Observational

Recruitment status

Recruiting

Enrolment

500 participants (estimated)

Lead sponsor

Tempus AIIndustry (pharma, biotech, devices)

Study start

26 Jun 2024 (actual)

Primary completion

1 Jun 2029 (estimated)

Study completion

1 Jun 2029 (estimated)

First posted

16 Jan 2024 (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.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

7

Who may qualify

Ages

18 to 99 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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

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

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

   Time frame: 5 years

   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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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
• Background: PubMed 29968853Abbosh 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.
• Background: PubMed 36796877Vellanki 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.
• 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/
• BackgroundUse 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: PubMed 31040929Beaubier 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.
• Background: PubMed 31570899Beaubier 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.
• Background: PubMed 34215841Finkle 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.

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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.

32 sites in 2 countries: see every site and its status.