CancerNCT06207032
TEMPUS ARIES: A Biobank Registry Platform Study in Oncology
An observational study of Cancer, run by Tempus AI at 32 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- How many people
- 500 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 26 Jun 2024to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with cancer willing to have additional blood samples collected for ctDNA research.
Who may be able to join
- ≥18 years of age
- Willing to participate in the research
- Able to provide informed consent
- Must be diagnosed with cancer
Who cannot join
- 1. Not willing or able to have additional blood samples collected
Trial locations and contacts
32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 2 countries
United States31 sites, 24 recruiting
- Recruiting
Morehouse
Atlanta, Georgia, 30310
Justyn Dawson, justyn.dawson@msm.edu
Roland Matthews
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30318
Jeff Whorton, Jeff.Whorton@piedmont.org
Sope Olugbile
- Terminated
New Jersey Cancer Center
Belleville, New Jersey, 07109
- Terminated
Regional Cancer Care Associates
Belleville, New Jersey, 07109
- Recruiting
Alabama Oncology
Birmingham, Alabama, 35233
Amanda Joseph, Amanda.Joseph@AlabamaOncology.com
Matthew Tucker, MD
- Recruiting
Aultman Medical Group
Canton, Ohio, 44710
Carla Larch, carla.larch@aultman.com
Razz Khan
- Recruiting
Southern Illinois Healthcare
Carterville, Illinois, 62918
Sarmad Nomani, sarmad.nomani@sih.net
Muhammad Popalzai
- Recruiting
Hematology Oncology Associates of Central NY
East Syracuse, New York, 13057
Nicole Coleman, ncoleman@hoacny.com
Ajeet Gajra, MD
- Recruiting
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
Shana Medeiros, Medeirossha@southcoast.org
Sonia Seng
- Recruiting
Sanford Roger Maris Cancer Center (Fargo)
Fargo, North Dakota, 58102
Angie Bruns, angela.bruns@sanfordhealth.org
Daniel Almquist
- Terminated
Fort Wayne
Fort Wayne, Indiana, 46804
- Recruiting
Frederick Health Regional System
Frederick, Maryland, 21702
Charity Drummond, cdrummond@frederick.health
Patrick Mansky
- Recruiting
Goshen Center for Cancer Care
Goshen, Indiana, 46526
Rachel Behrman, 5743642649, rbehrman@goshenhealth.com
James Wheeler, MD
- Recruiting
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri, 63401
Lindsey Gander, 573-629-3926, lindsey.gander@hannibalregional.org
Kevin Palka, MD
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Ellen Gustafson, sgustafson@hopenheal.care
Srilata Gundala
- Recruiting
Cayuga Medical Center
Ithaca, New York, 14850
Danielle Rao, 607-252-3939, drao@cayugamed.org
Nisha Ajit
- Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Erin Shephard, 904-538-4488, Erin.Shepard@CSNF.us
Mehdi Moezi
- Terminated
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
Jennifer Martinez, jmartinez@toledoclinic.com
John Nemunaitis, MD
- Terminated
St. Claire Healthcare
Morehead, Kentucky, 40351
- Recruiting
Eastern CT and Hematology and Oncology Associates
Norwich, Connecticut, 06360
James Champlin, 860-886-8362, jchamplin@echoct.com
Dennis Slater
- Recruiting
Cancer Care Specialists of Illinois
O'Fallon, Illinois, 62269
Kaitlynn Zeisset, kzeisset@ccsci.net
James Wade
- Recruiting
Lake Regional Health
Osage Beach, Missouri, 65065
Aleks Shin, ashin@lakeregional.com
Carla Ostronic
- Recruiting
Illinois Cancer Care
Peoria, Illinois, 61615
Carrey Geoffroy, cgeoffroy@illinoiscancercare.com
Pankaj Kumar
- Recruiting
Cancer Care Specialists - Reno
Reno, Nevada, 89511
Layla Tapia, 775-329-0222, ltapia@ccsreno.com
Aaron Bowman, MD
- Terminated
Northwest Oncology and Hematology
Rolling Meadows, Illinois, 60008
- Active, not recruiting
Mosaic Life Care
Saint Joseph, Missouri, 64506
- Recruiting
Cancer Care Northwest
Spokane, Washington, 99216
Joy Tinsen, Joy.Tinsen@ccnw.net
Nik Rademaker
- Recruiting
Oncology Hematology Associates
Springfield, Missouri, 65807
Roger Holden, 417-882-4880, roger.holden@aoncology.com
Robert Ellis, MD
- Recruiting
PIH Health Whittier Hospital & PIH Health Physicians
Whittier, California, 90605
Kristine Bradbury, 562-698-0811 ext. 12341, kristine.bradbury@pihhealth.org
Lisa Wang, MD
- Recruiting
Cancer Care Associates of York
York, Pennsylvania, 17403
Clarissa Vega, cvega@cancercareyork.com
Chanh Hyunh
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials
Rio Piedras, Puerto Rico, 00935
Josselyn Molina-Avila, MD, josselyn.molina@panoncologytrials.com
About this study
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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start26 Jun 2024
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Tempus AIThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tempus AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Ting-Lin, MD, Study director, Tempus AI, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207032
- Sponsor's protocol ID
- TP-CA-007
- Other IDs
- Pro00076336
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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/
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
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.
PubMed 29968853Vellanki 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.
PubMed 36796877Grayson 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/
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/
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.
PubMed 31040929Beaubier 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.
PubMed 31570899Finkle 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.
PubMed 34215841
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
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.
Key inclusion criteria (4 listed)
- ≥18 years of age
- Willing to participate in the research
- Able to provide informed consent
- Must be diagnosed with cancer
Key exclusion criteria (1 listed)
- 1. Not willing or able to have additional blood samples collected
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
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.
1 secondary outcome
Generation of DNA, RNA, immune and other multiomic datasets.
Time frame: 5 years
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.
Related trials for Cancer
Not yet recruiting
Using e-Technologies to Maximize Physical Activity After Cancer Treatment
Cancer
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Pharmacogenetic Determinants Of Treatment Response In Children
All Malignancies, Children Being Treated for Catastrophic Illness
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Michelle Ting-Lin, MD study director
Tempus AI, Inc.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Tempus AI at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Lopez (8007394137, aries@tempus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ctDNA from baseline, on-treatment and post-treatment blood samples. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207032, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.