Tempus Priority Study: A Pan-tumor Observational Study

April 2, 2024 updated by: Tempus AI

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • California
      • Napa, California, United States, 94558
        • Withdrawn
        • Providence Medical Foundation
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Withdrawn
        • Community Health
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Withdrawn
        • Pontchartrain Cancer Center
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Withdrawn
        • Central Care Cancer Center
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Withdrawn
        • New Jersey Cancer Center and Blood Disorders, New Jersey Cancer Care
    • New York
      • New York, New York, United States, 10016
        • Withdrawn
        • Perlmutter Cancer Center, NYU Langone Health
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Withdrawn
        • TriHealth Cancer Institute- Good Samaritan Hospital
      • Columbus, Ohio, United States, 43214
        • Withdrawn
        • OhioHealth
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Withdrawn
        • Oklahama Cancer Specialists and Research Institute
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Withdrawn
        • Cancer Care Associates of York
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern
        • Contact:
          • Donna Mitchell
          • Phone Number: 214-645-8789
        • Principal Investigator:
          • Woldu Solomon
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This protocol targets a broad spectrum of cancer patients with comprehensive genomic profiling.

Description

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.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / 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 understand longitudinal outcomes across institutions and standards of care.
Other: Observation
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Create robust data set of health information
Time Frame: 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
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Document clinical events for patients who have had comprehensive genomic profiling
Time Frame: Up to 10 years
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
Time Frame: 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
Up to 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Support prospective and retrospective research studies
Time Frame: Up to 10 years
To support prospective and retrospective research studies on participants with specific cancer types
Up to 10 years
Describe real world treatment outcomes
Time Frame: 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
Time Frame: Up to 10 years
To review medical information for standard of care decisions in the future and general health outcomes
Up to 10 years

Collaborators and Investigators

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

Sponsor

Tempus AI

Investigators

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

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

October 19, 2030

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-CA-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on Observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe