TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

Recruiting

• Conditions: Cancer

• Registration Number: NCT06207032
• Lead Sponsor: Tempus AI

Brief Summary

This study is a non-interventional, multicenter, multicohort evaluation of participants with cancer who will undergo longitudinal plasma ctDNA biomarker profiling at specific time points in addition to standard of care therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-16
• Study Start: 2024-06-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2029-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. ≥18 years of age
2. Willing to participate in the research
3. Able to provide informed consent
4. Must be diagnosed with cancer

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Exclusion Criteria

1. Not willing or able to have additional blood samples collected

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in ctDNA from baseline, on-treatment and post-treatment blood samples.	5 years	Assess ctDNA kinetics using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, and time to ctDNA recurrence and correlate with standard of care therapy real-world outcomes such as overall survival, progression-free survival, time to next treatment, and time to treatment discontinuation.

Secondary Outcome Measures

Name	Time	Method
Generation of DNA, RNA, immune and other multiomic datasets.	5 years	Use blood and tissue based next generation sequencing to uncover biomarkers that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.

Trial Locations

Locations (21)

Frederick Health Regional System; 🇺🇸 Frederick, Maryland, United States

Alabama Oncology; 🇺🇸 Birmingham, Alabama, United States

Eastern CT and Hematology and Oncology Associates; 🇺🇸 Norwich, Connecticut, United States

Southern Illinois Healthcare; 🇺🇸 Carterville, Illinois, United States

Hope and Healing Cancer Services; 🇺🇸 Hinsdale, Illinois, United States

Cancer Care Specialists of Illinois; 🇺🇸 O'Fallon, Illinois, United States

Illinois Cancer Care; 🇺🇸 Peoria, Illinois, United States

Northwest Oncology and Hematology; 🇺🇸 Rolling Meadows, Illinois, United States

Fort Wayne; 🇺🇸 Fort Wayne, Indiana, United States

Goshen Center for Cancer Care; 🇺🇸 Goshen, Indiana, United States

St. Claire Healthcare; 🇺🇸 Morehead, Kentucky, United States

Southcoast Centers for Cancer Care; 🇺🇸 Fairhaven, Massachusetts, United States

Lake Regional Health; 🇺🇸 Osage Beach, Missouri, United States

Oncology Hematology Associates; 🇺🇸 Springfield, Missouri, United States

Hope Cancer Care of Nevada; 🇺🇸 Las Vegas, Nevada, United States

New Jersey Cancer Center; 🇺🇸 Belleville, New Jersey, United States

Regional Cancer Care Associates; 🇺🇸 Belleville, New Jersey, United States

Hematology Oncology Associates of Central NY; 🇺🇸 East Syracuse, New York, United States

Cayuga Medical Center; 🇺🇸 Ithaca, New York, United States

Taylor Cancer Research Center; 🇺🇸 Maumee, Ohio, United States

Cancer Care Associates of York; 🇺🇸 York, Pennsylvania, United States