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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00076336 | Other Identifier | Advarra |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Not willing or able to have additional blood samples collected
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Participants diagnosed with cancer willing to have additional blood samples collected for ctDNA research.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Lopez | Contact | 8007394137 | aries@tempus.com |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Ting-Lin, MD | Tempus AI, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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/ | ||
| 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 | ||
| 29968853 | 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. | |
| 36796877 |
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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.
| PIH Health Whittier Hospital & PIH Health Physicians | Recruiting | Whittier | California | 90605 | United States |
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| Eastern CT and Hematology and Oncology Associates | Recruiting | Norwich | Connecticut | 06360 | United States |
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| Cancer Specialists of North Florida | Recruiting | Jacksonville | Florida | 32256 | United States |
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| Morehouse | Recruiting | Atlanta | Georgia | 30310 | United States |
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| Piedmont Healthcare | Recruiting | Atlanta | Georgia | 30318 | United States |
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| Southern Illinois Healthcare | Recruiting | Carterville | Illinois | 62918 | United States |
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| Hope and Healing Cancer Services | Recruiting | Hinsdale | Illinois | 60521 | United States |
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| Cancer Care Specialists of Illinois | Recruiting | O'Fallon | Illinois | 62269 | United States |
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| Illinois Cancer Care | Recruiting | Peoria | Illinois | 61615 | United States |
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| Northwest Oncology and Hematology | Terminated | Rolling Meadows | Illinois | 60008 | United States |
| Fort Wayne | Terminated | Fort Wayne | Indiana | 46804 | United States |
| Goshen Center for Cancer Care | Recruiting | Goshen | Indiana | 46526 | United States |
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| St. Claire Healthcare | Terminated | Morehead | Kentucky | 40351 | United States |
| Frederick Health Regional System | Recruiting | Frederick | Maryland | 21702 | United States |
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| Southcoast Centers for Cancer Care | Recruiting | Fairhaven | Massachusetts | 02719 | United States |
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| Hannibal Regional Healthcare System, Inc. | Recruiting | Hannibal | Missouri | 63401 | United States |
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| Lake Regional Health | Recruiting | Osage Beach | Missouri | 65065 | United States |
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| Mosaic Life Care | Active, not recruiting | Saint Joseph | Missouri | 64506 | United States |
| Oncology Hematology Associates | Recruiting | Springfield | Missouri | 65807 | United States |
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| Hope Cancer Care of Nevada | Terminated | Las Vegas | Nevada | 89103 | United States |
| Cancer Care Specialists - Reno | Recruiting | Reno | Nevada | 89511 | United States |
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| New Jersey Cancer Center | Terminated | Belleville | New Jersey | 07109 | United States |
| Regional Cancer Care Associates | Terminated | Belleville | New Jersey | 07109 | United States |
| Hematology Oncology Associates of Central NY | Recruiting | East Syracuse | New York | 13057 | United States |
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| Cayuga Medical Center | Recruiting | Ithaca | New York | 14850 | United States |
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| Sanford Roger Maris Cancer Center (Fargo) | Recruiting | Fargo | North Dakota | 58102 | United States |
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| Aultman Medical Group | Recruiting | Canton | Ohio | 44710 | United States |
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| Taylor Cancer Research Center | Recruiting | Maumee | Ohio | 43537 | United States |
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| Cancer Care Associates of York | Recruiting | York | Pennsylvania | 17403 | United States |
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| Cancer Care Northwest | Recruiting | Spokane | Washington | 99216 | United States |
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| Pan American Center for Oncology Trials | Recruiting | Rio Piedras | Puerto Rico | 00935 | Puerto Rico |
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| Background |
| 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. |
| Background | 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/ |
| 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/ |
| 31040929 | 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. |
| 31570899 | Background | 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. |
| 34215841 | Background | 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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