Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays
NCT ID: NCT05234177
Last Updated: 2025-05-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
300 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-06-21
Study Completion Date
2029-02-28
Brief Summary
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The study is an observational multicenter evaluation of participants with colorectal cancer (CRC) who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease surveillance.
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Detailed Description
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Conditions
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Colorectal Cancer
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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Participants with stage I-IV colorectal cancer (CRC)
This protocol will include participants with stage I-IV CRC who are scheduled to undergo or have undergone a surgical resection with curative intent.
Observation
Intervention Type
OTHER
No intervention
Interventions
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Observation
No intervention
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Known or suspected colorectal adenocarcinoma (Stage I to IVA disease)
* Planning to undergo or has undergone a surgical resection for suspected adenocarcinoma of the colon or rectum with curative intent.
* 18 years old or older
* Willing and able to provide informed consent
* Willing to have additional blood samples collected during routine surveillance visits
* Planning to undergo or has undergone a surgical resection for suspected adenocarcinoma of the colon or rectum with curative intent.
* 18 years old or older
* Willing and able to provide informed consent
* Willing to have additional blood samples collected during routine surveillance visits
Exclusion Criteria
* Not willing to have additional blood samples collected
* Pathology that is not consistent with colorectal adenocarcinoma
* Pathology that is not consistent with colorectal adenocarcinoma
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Tempus AI
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Kristiyana Kaneva, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Tempus AI, Inc.
Locations
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Mercy Clinic Oncology - Fort Smith
Fort Smith, Arkansas, United States
Site Status
RECRUITING
MemorialCare
Fountain Valley, California, United States
Site Status
RECRUITING
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - Joplin
Joplin, Missouri, United States
Site Status
RECRUITING
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
Springfield, Missouri, United States
Site Status
RECRUITING
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
St Louis, Missouri, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
St Louis, Missouri, United States
Site Status
RECRUITING
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Site Status
RECRUITING
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Site Status
RECRUITING
Aultman Hospital
Canton, Ohio, United States
Site Status
RECRUITING
TriHealth Cancer Institute
Cincinnati, Ohio, United States
Site Status
RECRUITING
Ohio State University
Columbus, Ohio, United States
Site Status
RECRUITING
OhioHealth Research Institute
Columbus, Ohio, United States
Site Status
RECRUITING
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Site Status
RECRUITING
Mercy Clinic Oncology and Hematology - Coletta
Oklahoma City, Oklahoma, United States
Site Status
RECRUITING
Cancer Care Associates of York
York, Pennsylvania, United States
Site Status
RECRUITING
Utah Cancer Specialists
Salt Lake City, Utah, United States
Site Status
RECRUITING
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, United States
Site Status
RECRUITING
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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TP-CA-004
Identifier Type: -
Identifier Source: org_study_id
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