Clinical trial NCT05179824: Tempus Priority Study: A Pan-tumor Observational Study
Official title: Tempus Priority Study: An Observational Study of Patients Who Have Received Comprehensive Genomic Profiling
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: 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
Keywords: Cancer
Oncology
Observational
Genomic Profiling
Precision Medicine
Lead sponsor: Tempus AI
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This protocol targets a broad spectrum of cancer patients with comprehensive genomic profiling.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Create robust data set of health information
timeFrame: Up to 10 years
Secondary outcomes:
measure: Document clinical events for patients who have had comprehensive genomic profiling
timeFrame: Up to 10 years
measure: Evaluate longitudinal paired tissue and cell free molecular testing
timeFrame: Up to 10 years
Other outcomes:
measure: Support prospective and retrospective research studies
timeFrame: Up to 10 years
measure: Describe real world treatment outcomes
timeFrame: Up to 10 years
measure: Review medical information for standard of care decisions and health outcomes
timeFrame: Up to 10 years
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Tempus AI, Inc.
name: Kristiyana Kaneva, MD, MS, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.