Tempus Priority Study: A Pan-tumor Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tempus Priority Study: An Observational Study of Patients Who Have Received Comprehensive Genomic Profiling

Conditions
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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

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid or hematologic malignancy. Willing and able to provide informed consent where required. Has received or will receive genomic profiling. Exclusion Criteria: Individuals without the capacity to consent. Prisoners at the time of enrollment. I/E criteria are specific for each cohort of Group 2 and available in the full protocol.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Standard of Care (SOC) CGP<br>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. | Other: Observation<br>* No Intervention<br>|
| Group 2: Disease or Profile Specific Cohorts<br>Group 2 will consist of specific cohorts that will facilitate collection of paired clinical and molecular data done outside of the standard of care, longitudinal CGP, or narrowly defined cohorts based on mutations or treatment settings. The goal of Group 2 is to capture specific participants in specific cohorts to better understand longitudinal outcomes across institutions and standards of care. Protocol contains complete eligibility criteria. | Other: Observation<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oncology, Observational, Genomic Profiling, Precision Medicine