Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT06207032
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TEMPUS ARIES: A Biobank Registry Platform Study in Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in ctDNA from baseline, on-treatment and post-treatment blood samples.', 'timeFrame': '5 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Generation of DNA, RNA, immune and other multiomic datasets.', 'timeFrame': '5 years', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ctDNA', 'Next-Generation Sequencing', 'Oncology'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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/'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '29968853', 'type': 'BACKGROUND', 'citation': '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': '36796877', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', '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/'}, {'type': 'BACKGROUND', 'citation': '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/'}, {'pmid': '31040929', 'type': 'BACKGROUND', '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.'}, {'pmid': '31570899', 'type': 'BACKGROUND', '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.'}, {'pmid': '34215841', 'type': 'BACKGROUND', '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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with cancer willing to have additional blood samples collected for ctDNA research.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years of age\n2. Willing to participate in the research\n3. Able to provide informed consent\n4. Must be diagnosed with cancer\n\nExclusion Criteria:\n\n1\\. Not willing or able to have additional blood samples collected'}, 'identificationModule': {'nctId': 'NCT06207032', 'briefTitle': 'TEMPUS ARIES: A Biobank Registry Platform Study in Oncology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tempus AI'}, 'officialTitle': 'TEMPUS ARIES: A Biobank Registry Platform Study in Oncology', 'orgStudyIdInfo': {'id': 'TP-CA-007'}, 'secondaryIdInfos': [{'id': 'Pro00076336', 'type': 'OTHER', 'domain': 'Advarra'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 001: KRAS mutated CRC', 'description': 'No intervention.'}, {'label': 'Cohort 002: KRAS mutated PDAC', 'description': 'No intervention.'}, {'label': 'Cohort 003: KRAS mutated NSCLC', 'description': 'No intervention.'}, {'label': 'Cohort 004: Gastric 1L Plus', 'description': 'No intervention.'}, {'label': 'Cohort 005: mCRPC 1L Plus', 'description': 'No intervention.'}, {'label': 'Cohort 006: Pan Tumor ADCs', 'description': 'No intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Joseph', 'role': 'CONTACT', 'email': 'Amanda.Joseph@AlabamaOncology.com'}, {'name': 'Matthew Tucker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alabama Oncology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90605', 'city': 'Whittier', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristine Bradbury', 'role': 'CONTACT', 'email': 'kristine.bradbury@pihhealth.org', 'phone': '562-698-0811', 'phoneExt': '12341'}, {'name': 'Lisa Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PIH Health Whittier Hospital & PIH Health Physicians', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Champlin', 'role': 'CONTACT', 'email': 'jchamplin@echoct.com', 'phone': '860-886-8362'}, {'name': 'Dennis Slater', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eastern CT and Hematology and Oncology Associates', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Shephard', 'role': 'CONTACT', 'email': 'Erin.Shepard@CSNF.us', 'phone': '904-538-4488'}, {'name': 'Mehdi Moezi', 'role': 'CONTACT'}], 'facility': 'Cancer Specialists of North Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justyn Dawson', 'role': 'CONTACT', 'email': 'justyn.dawson@msm.edu'}, {'name': 'Roland Matthews', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Morehouse', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '62918', 'city': 'Carterville', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarmad Nomani', 'role': 'CONTACT', 'email': 'sarmad.nomani@sih.net'}, {'name': 'Muhammad Popalzai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Illinois Healthcare', 'geoPoint': {'lat': 37.76005, 'lon': -89.0773}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Gustafson', 'role': 'CONTACT', 'email': 'sgustafson@hopenheal.care'}, {'name': 'Srilata Gundala', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hope and Healing Cancer Services', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '62269', 'city': "O'Fallon", 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaitlynn Zeisset', 'role': 'CONTACT', 'email': 'kzeisset@ccsci.net'}, {'name': 'James Wade', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Care Specialists of Illinois', 'geoPoint': {'lat': 38.59227, 'lon': -89.91121}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carrey Geoffroy', 'role': 'CONTACT', 'email': 'cgeoffroy@illinoiscancercare.com'}, {'name': 'Pankaj Kumar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois Cancer Care', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Chukwuocha', 'role': 'CONTACT', 'email': 'christinec@northwestoncology.com'}, {'name': 'Dr. Bruce Bank', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwest Oncology and Hematology', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raven Carter', 'role': 'CONTACT', 'email': 'raven.carter@fwmoh.com'}, {'name': 'Dr. Ahad Sadiq', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fort Wayne', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46526', 'city': 'Goshen', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Behrman', 'role': 'CONTACT', 'email': 'rbehrman@goshenhealth.com', 'phone': '5743642649'}, {'name': 'James Wheeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Goshen Center for Cancer Care', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}, {'zip': '40351', 'city': 'Morehead', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Kelsey', 'role': 'CONTACT', 'email': 'elizabeth.kelsey@st-claire.org'}, {'name': 'Mike Brunet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Claire Healthcare', 'geoPoint': {'lat': 37.27115, 'lon': -87.17638}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charity Drummond', 'role': 'CONTACT', 'email': 'cdrummond@frederick.health'}, {'name': 'Patrick Mansky', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Frederick Health Regional System', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '02719', 'city': 'Fairhaven', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shana Medeiros', 'role': 'CONTACT', 'email': 'Medeirossha@southcoast.org'}, {'name': 'Sonia Seng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southcoast Centers for Cancer Care', 'geoPoint': {'lat': 41.6376, 'lon': -70.90365}}, {'zip': '63401', 'city': 'Hannibal', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsey Gander', 'role': 'CONTACT', 'email': 'lindsey.gander@hannibalregional.org', 'phone': '573-629-3926'}, {'name': 'Kevin Palka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hannibal Regional Healthcare System, Inc.', 'geoPoint': {'lat': 39.70838, 'lon': -91.35848}}, {'zip': '65065', 'city': 'Osage Beach', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aleks Shin', 'role': 'CONTACT', 'email': 'ashin@lakeregional.com'}, {'name': 'Carla Ostronic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lake Regional Health', 'geoPoint': {'lat': 38.12956, 'lon': -92.65277}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roger Holden', 'role': 'CONTACT', 'email': 'roger.holden@aoncology.com', 'phone': '417-882-4880'}, {'name': 'Robert Ellis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncology Hematology Associates', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '89103', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Gatdula, CRC', 'role': 'CONTACT', 'email': 'Mark.Gatdula@aoncology.com', 'phone': '702-508-9128'}, {'name': 'Raja Mehdi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hope Cancer Care of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89511', 'city': 'Reno', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Layla Tapia', 'role': 'CONTACT', 'email': 'ltapia@ccsreno.com', 'phone': '775-329-0222'}, {'name': 'Aaron Bowman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Care Specialists - Reno', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07109', 'city': 'Belleville', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Johnstone', 'role': 'CONTACT', 'email': 'trials@njcancercare.com'}, {'name': 'Hannah Oliveira', 'role': 'CONTACT', 'email': 'holiveira@njcancercare.com', 'phone': '973-751-8880', 'phoneExt': '272'}, {'name': 'James Orsini, Jr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Jersey Cancer Center', 'geoPoint': {'lat': 40.79371, 'lon': -74.15014}}, {'zip': '07109', 'city': 'Belleville', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Johnstone', 'role': 'CONTACT', 'email': 'mjohnstone@njcancercare.com'}, {'name': 'James Orsini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regional Cancer Care Associates', 'geoPoint': {'lat': 40.79371, 'lon': -74.15014}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Coleman', 'role': 'CONTACT', 'email': 'ncoleman@hoacny.com'}, {'name': 'Ajeet Gajra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hematology Oncology Associates of Central NY', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '14850', 'city': 'Ithaca', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Betty Haverlock', 'role': 'CONTACT', 'email': 'bhaverlock@cayugamed.org', 'phone': '607-252-3939'}, {'name': 'Anthony Mato', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cayuga Medical Center', 'geoPoint': {'lat': 42.44063, 'lon': -76.49661}}, {'zip': '58102', 'city': 'Fargo', 'state': 'North Dakota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angie Bruns', 'role': 'CONTACT', 'email': 'angela.bruns@sanfordhealth.org'}, {'name': 'Daniel Almquist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sanford Roger Maris Cancer Center (Fargo)', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Martinez', 'role': 'CONTACT', 'email': 'jmartinez@toledoclinic.com'}, {'name': 'John Nemunaitis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taylor Cancer Research Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clarissa Vega', 'role': 'CONTACT', 'email': 'cvega@cancercareyork.com'}, {'name': 'Chanh Hyunh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Care Associates of York', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '00935', 'city': 'Rio Piedras', 'state': 'Puerto Rico', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'name': 'Josselyn Molina-Avila, MD', 'role': 'CONTACT', 'email': 'josselyn.molina@panoncologytrials.com'}], 'facility': 'Pan American Center for Oncology Trials', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}], 'centralContacts': [{'name': 'Lauren Lopez', 'role': 'CONTACT', 'email': 'aries@tempus.com', 'phone': '8007394137'}], 'overallOfficials': [{'name': 'Michelle Ting-Lin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tempus AI, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tempus AI', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}