Tempus Priority Study: A Pan-tumor Observational Study

Sponsor

Tempus Labs (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05179824

Collaborator

(none)

1,000

Enrollment

Locations

120

Anticipated Duration (Months)

125

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 19, 2020

Anticipated Primary Completion Date :

Oct 19, 2026

Anticipated Study Completion Date :

Oct 19, 2030

Arms and Interventions

Arm	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
Group 2: Disease or Profile Specific Cohorts 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 No Intervention

Arm

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

Group 2: Disease or Profile Specific Cohorts

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

No Intervention

Outcome Measures

Primary Outcome Measures

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

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
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

Other Outcome Measures

Support prospective and retrospective research studies [Up to 10 years]
To support prospective and retrospective research studies on participants with specific cancer types
Describe real world treatment outcomes [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)
Review medical information for standard of care decisions and health outcomes [Up to 10 years]
To review medical information for standard of care decisions in the future and general health outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pontchartrain Cancer Center	Covington	Louisiana	United States	70433
2	Central Care Cancer Center	Bolivar	Missouri	United States	65613
3	New Jersey Cancer Center and Blood Disorders, New Jersey Cancer Care	Belleville	New Jersey	United States	07109
4	Perlmutter Cancer Center, NYU Langone Health	New York	New York	United States	10016
5	TriHealth Cancer Institute- Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
6	OhioHealth	Columbus	Ohio	United States	43214
7	Cancer Care Associates of York	York	Pennsylvania	United States	17403
8	Baylor College of Medicine	Houston	Texas	United States	77030