TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

NCT ID: NCT06207032

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-26

Study Completion Date

2029-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 001: KRAS mutated CRC

No intervention.

No interventions assigned to this group

Cohort 002: KRAS mutated PDAC

No intervention.

No interventions assigned to this group

Cohort 003: KRAS mutated NSCLC

No intervention.

No interventions assigned to this group

Cohort 004: Gastric 1L Plus

No intervention.

No interventions assigned to this group

Cohort 005: mCRPC 1L Plus

No intervention.

No interventions assigned to this group

Cohort 006: Pan Tumor ADCs

No intervention.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tempus AI

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Ting-Lin, MD

Role: STUDY_DIRECTOR

Tempus AI, Inc.

Locations

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Alabama Oncology

Birmingham, Alabama, United States

Site Status RECRUITING

PIH Health Whittier Hospital & PIH Health Physicians

Whittier, California, United States

Site Status RECRUITING

Eastern CT and Hematology and Oncology Associates

Norwich, Connecticut, United States

Site Status RECRUITING

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Morehouse

Atlanta, Georgia, United States

Site Status RECRUITING

Southern Illinois Healthcare

Carterville, Illinois, United States

Site Status RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois

O'Fallon, Illinois, United States

Site Status RECRUITING

Illinois Cancer Care

Peoria, Illinois, United States

Site Status RECRUITING

Northwest Oncology and Hematology

Rolling Meadows, Illinois, United States

Site Status RECRUITING

Fort Wayne

Fort Wayne, Indiana, United States

Site Status RECRUITING

Goshen Center for Cancer Care

Goshen, Indiana, United States

Site Status RECRUITING

St. Claire Healthcare

Morehead, Kentucky, United States

Site Status RECRUITING

Frederick Health Regional System

Frederick, Maryland, United States

Site Status RECRUITING

Southcoast Centers for Cancer Care

Fairhaven, Massachusetts, United States

Site Status RECRUITING

Hannibal Regional Healthcare System, Inc.

Hannibal, Missouri, United States

Site Status RECRUITING

Lake Regional Health

Osage Beach, Missouri, United States

Site Status RECRUITING

Oncology Hematology Associates

Springfield, Missouri, United States

Site Status RECRUITING

Hope Cancer Care of Nevada

Las Vegas, Nevada, United States

Site Status RECRUITING

Cancer Care Specialists - Reno

Reno, Nevada, United States

Site Status RECRUITING

New Jersey Cancer Center

Belleville, New Jersey, United States

Site Status RECRUITING

Regional Cancer Care Associates

Belleville, New Jersey, United States

Site Status RECRUITING

Hematology Oncology Associates of Central NY

East Syracuse, New York, United States

Site Status RECRUITING

Cayuga Medical Center

Ithaca, New York, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center (Fargo)

Fargo, North Dakota, United States

Site Status RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, United States

Site Status RECRUITING

Cancer Care Associates of York

York, Pennsylvania, United States

Site Status RECRUITING

Pan American Center for Oncology Trials

Rio Piedras, Puerto Rico, Puerto Rico

Site Status RECRUITING

Countries

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United States Puerto Rico

Central Contacts

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Lauren Lopez

Role: CONTACT

8007394137

Facility Contacts

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Amanda Joseph

Role: primary

Kristine Bradbury

Role: primary

562-698-0811 ext. 12341

James Champlin

Role: primary

860-886-8362

Erin Shephard

Role: primary

904-538-4488

Mehdi Moezi

Role: backup

Justyn Dawson

Role: primary

Sarmad Nomani

Role: primary

Ellen Gustafson

Role: primary

Kaitlynn Zeisset

Role: primary

Carrey Geoffroy

Role: primary

Christine Chukwuocha

Role: primary

Raven Carter

Role: primary

Rachel Behrman

Role: primary

5743642649

Elizabeth Kelsey

Role: primary

Charity Drummond

Role: primary

Shana Medeiros

Role: primary

Lindsey Gander

Role: primary

573-629-3926

Aleks Shin

Role: primary

Roger Holden

Role: primary

417-882-4880

Mark Gatdula, CRC

Role: primary

702-508-9128

Layla Tapia

Role: primary

775-329-0222

Anthony Johnstone

Role: primary

Hannah Oliveira

Role: backup

973-751-8880 ext. 272

Michael Johnstone

Role: primary

Nicole Coleman

Role: primary

Betty Haverlock

Role: primary

607-252-3939

Angie Bruns

Role: primary

Jennifer Martinez

Role: primary

Clarissa Vega

Role: primary

Josselyn Molina-Avila, MD

Role: primary

References

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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/

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 29968853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36796877 (View on PubMed)

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/

Reference Type 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/

Reference Type 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.

Reference Type BACKGROUND
PMID: 31040929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31570899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34215841 (View on PubMed)

Other Identifiers

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Pro00076336

Identifier Type: OTHER

Identifier Source: secondary_id

TP-CA-007

Identifier Type: -

Identifier Source: org_study_id

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