Tempus Priority Study: A Pan-tumor Observational Study

Active, not recruiting

• Conditions: Breast Cancer; Ovarian Cancer; Cancer of Head and Neck; Cancer of Gastrointestinal Tract; Cancer of Kidney; Lymphoma; Bladder Cancer; Brain Cancer; Pancreatic Cancer; Fallopian Tube Cancer
• Interventions: Other: Observation

• Registration Number: NCT05179824
• Lead Sponsor: Tempus AI

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.

Study Timeline

• Study Start: 2020-10-19
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-10-19
• Study Completion: 2030-10-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

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Exclusion Criteria

1. Individuals without the capacity to consent.
2. Prisoners at the time of enrollment.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Standard of Care (SOC) CGP	Observation	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.

Primary Outcome Measures

Name	Time	Method
Create robust data set of health information	Up to 10 years	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

Secondary Outcome Measures

Name	Time	Method
Evaluate longitudinal paired tissue and cell free molecular testing	Up to 10 years	To evaluate the feasibility of longitudinal paired tissue and cell free molecular testing of participants with specific types of cancer, mutations, or therapies
Document clinical events for patients who have had comprehensive genomic profiling	Up to 10 years	To document specific clinical events in relation to diagnosis, treatment, and outcomes for patients who have had comprehensive genomic profiling

Trial Locations

Locations (2)

UT Southwestern; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States