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Tempus Priority Study: A Pan-tumor Observational Study


2020-10-19


2026-10-19


2030-10-19


1000

Study Overview

Tempus Priority Study: A Pan-tumor Observational Study

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.

  • Breast Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Lung Cancer
  • Brain Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Cancer of Liver
  • Cancer of Colon
  • Cancer of Head and Neck
  • Cancer of Stomach
  • Cancer of Gastrointestinal Tract
  • Cancer of Rectum
  • Cancer of Esophagus
  • Cancer of Skin
  • Cancer of Cervix
  • Cancer of Kidney
  • Cancer of Larynx
  • Cancer of Endometrium
  • Cancer of the Bile Duct
  • Cancer of Vulva
  • Cancer of Bone and Connective Tissue
  • Leukemia
  • Lymphoma
  • Spinal Cord Cancer
  • OTHER: Observation
  • TP-CA-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-12-16  

N/A  

2025-05-05  

2021-12-16  

N/A  

2025-05-06  

2022-01-05  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: 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 understan

OTHER: Observation

  • No Intervention
Primary Outcome MeasuresMeasure DescriptionTime Frame
Create robust data set of health informationTo create a robust data set of health information about cancer patients who receive comprehensive genomic profiling in order to facilitate future novel precision medicine researchUp to 10 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Document clinical events for patients who have had comprehensive genomic profilingTo document specific clinical events in relation to diagnosis, treatment, and outcomes for patients who have had comprehensive genomic profilingUp to 10 years
Evaluate longitudinal paired tissue and cell free molecular testingTo evaluate the feasibility of longitudinal paired tissue and cell free molecular testing of participants with specific types of cancer, mutations, or therapiesUp to 10 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Solid or hematologic malignancy. 2. Willing and able to provide informed consent where required. 3. Has received or will receive genomic profiling.
    Exclusion Criteria:
    1. Individuals without the capacity to consent. 2. Prisoners at the time of enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Kristiyana Kaneva, MD, MS, MBA, Tempus AI, Inc.

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • 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.
    • 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.
    • 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.
    • 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.