TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

Cancer Clinical Trial

Official title:

TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207032
• Other study ID #: TP-CA-007
• Secondary ID: Pro00076336
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2029

Study information

• Verified date: May 2024
• Source: Tempus AI
• Contact: Lauren Lopez
• Phone: 8007394137
• Email: aries[@]tempus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2029
• Est. primary completion date: June 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Locations

Country	Name	City	State
United States	New Jersey Cancer Center	Belleville	New Jersey
United States	Hope and Healing Cancer Services	Hinsdale	Illinois
United States	Cayuga Medical Center	Ithaca	New York
United States	Eastern CT and Hematology and Oncology Associates	Norwich	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Tempus AI

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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/

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

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/

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/

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Generation of DNA, RNA, immune and other multiomic datasets.	Use blood and tissue based next generation sequencing to uncover biomarkers that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.	5 years