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Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with the goal of conducting research to advance cancer care and create a dataset that furthers cancer research.
The Study will collect combined clinical and molecular health information for cancer patients in the United States from multiple academic medical centers and community oncology practices. Participants who agree to join the Study will have their molecular profiling results, associated clinical health information, and longitudinal outcomes health information collected by the participating Institution for submission to Tempus. The specific goal of the Study is to create an outcomes-based dataset for future research to improve cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Standard of Care (SOC) CGP | This group will facilitate collection of paired clinical and molecular data done as part of the standard of care or routine clinical care across a variety of institutions. The goal of Group 1 is to capture a broad range of participants to better understand longitudinal outcomes across institutions and standards of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Create robust data set of health information | To create a robust data set of health information about cancer patients who receive comprehensive genomic profiling in order to facilitate future novel precision medicine research | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Document clinical events for patients who have had comprehensive genomic profiling | To document specific clinical events in relation to diagnosis, treatment, and outcomes for patients who have had comprehensive genomic profiling | Up to 10 years |
| Evaluate longitudinal paired tissue and cell free molecular testing |
| Measure | Description | Time Frame |
|---|---|---|
| Support prospective and retrospective research studies | To support prospective and retrospective research studies on participants with specific cancer types | Up to 10 years |
| Describe real world treatment outcomes |
Inclusion Criteria:
Exclusion Criteria:
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This protocol targets a broad spectrum of cancer patients with comprehensive genomic profiling.
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| Name | Affiliation | Role |
|---|---|---|
| Kristiyana Kaneva, MD, MS, MBA | Tempus AI, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern | Dallas | Texas | 75390 | United States | ||
| Baylor College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28481359 | Background | Zehir A, Benayed R, Shah RH, Syed A, Middha S, Kim HR, Srinivasan P, Gao J, Chakravarty D, Devlin SM, Hellmann MD, Barron DA, Schram AM, Hameed M, Dogan S, Ross DS, Hechtman JF, DeLair DF, Yao J, Mandelker DL, Cheng DT, Chandramohan R, Mohanty AS, Ptashkin RN, Jayakumaran G, Prasad M, Syed MH, Rema AB, Liu ZY, Nafa K, Borsu L, Sadowska J, Casanova J, Bacares R, Kiecka IJ, Razumova A, Son JB, Stewart L, Baldi T, Mullaney KA, Al-Ahmadie H, Vakiani E, Abeshouse AA, Penson AV, Jonsson P, Camacho N, Chang MT, Won HH, Gross BE, Kundra R, Heins ZJ, Chen HW, Phillips S, Zhang H, Wang J, Ochoa A, Wills J, Eubank M, Thomas SB, Gardos SM, Reales DN, Galle J, Durany R, Cambria R, Abida W, Cercek A, Feldman DR, Gounder MM, Hakimi AA, Harding JJ, Iyer G, Janjigian YY, Jordan EJ, Kelly CM, Lowery MA, Morris LGT, Omuro AM, Raj N, Razavi P, Shoushtari AN, Shukla N, Soumerai TE, Varghese AM, Yaeger R, Coleman J, Bochner B, Riely GJ, Saltz LB, Scher HI, Sabbatini PJ, Robson ME, Klimstra DS, Taylor BS, Baselga J, Schultz N, Hyman DM, Arcila ME, Solit DB, Ladanyi M, Berger MF. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nat Med. 2017 Jun;23(6):703-713. doi: 10.1038/nm.4333. Epub 2017 May 8. | |
| 29034207 |
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Archival tissue will be collected.
To evaluate the feasibility of longitudinal paired tissue and cell free molecular testing of participants with specific types of cancer, mutations, or therapies |
| Up to 10 years |
To describe real world treatment outcomes (such as real-world response, real world duration of response, real world progression free survival, real world time to next treatment, real world time to treatment discontinuation, and overall survival)
| Up to 10 years |
| Review medical information for standard of care decisions and health outcomes | To review medical information for standard of care decisions in the future and general health outcomes | Up to 10 years |
| Houston |
| Texas |
| 77030 |
| United States |
| Background |
| Daoud A, Chu QS. Targeting Novel but Less Common Driver Mutations and Chromosomal Translocations in Advanced Non-Small Cell Lung Cancer. Front Oncol. 2017 Sep 29;7:222. doi: 10.3389/fonc.2017.00222. eCollection 2017. |
| 30231363 | Background | Ersek JL, Black LJ, Thompson MA, Kim ES. Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices. Am Soc Clin Oncol Educ Book. 2018 May 23;38:188-196. doi: 10.1200/EDBK_200633. |
| 31140124 | Background | Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA. Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer. Adv Ther. 2019 Aug;36(8):2122-2136. doi: 10.1007/s12325-019-00970-1. Epub 2019 May 28. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D008175 | Lung Neoplasms |
| D001932 | Brain Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D008113 | Liver Neoplasms |
| D003110 | Colonic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013274 | Stomach Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D012004 | Rectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D012878 | Skin Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D007680 | Kidney Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D016889 | Endometrial Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D014846 | Vulvar Neoplasms |
| D001859 | Bone Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D008107 | Liver Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D012002 | Rectal Diseases |
| D004935 | Esophageal Diseases |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D007674 | Kidney Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D007818 | Laryngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D014845 | Vulvar Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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