Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays

May 5, 2025 updated by: Tempus AI

Tempus CRC Surveillance Study: A Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Colorectal Cancer (CRC) Using Comprehensive Next-Generation Sequencing (NGS)Assays

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

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
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Clinic Oncology - Fort Smith
        • Contact:
        • Principal Investigator:
          • Aswanth Reddy, MD
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • MemorialCare
        • Principal Investigator:
          • Amol Rao, MD
        • Contact:
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • The Center for Cancer and Blood Disorders
        • Principal Investigator:
          • Mark Goldstein, MD
        • Contact:
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Clinic Oncology and Hematology - Joplin
        • Principal Investigator:
          • Samir Dalia, MD
        • Contact:
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Ryan Fields, MD
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Clinic Oncology and Hematology - Sindelar Cancer Center
        • Contact:
        • Principal Investigator:
          • Yifan Tu, MD
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
        • Principal Investigator:
          • Bethany Sleckman, MD
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center
        • Contact:
        • Principal Investigator:
          • Mohan Tummala, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
        • Principal Investigator:
          • Timothy Huyck, MD
        • Contact:
    • North Carolina
      • Goldsboro, North Carolina, United States, 27543
        • Recruiting
        • Southeastern Medical Oncology Center
        • Contact:
        • Principal Investigator:
          • Samer Kasbari, MD
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Hospital
        • Contact:
        • Principal Investigator:
          • Adarsh Vennepureddy, MD
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Cancer Institute
        • Principal Investigator:
          • Benjamin Kuritzky, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Arjun Mittra, MD
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research Institute
        • Principal Investigator:
          • Arvinder Bhinder, MD
        • Contact:
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Toledo Clinic Cancer Center
        • Principal Investigator:
          • John Nemunaitis, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Clinic Oncology and Hematology - Coletta
        • Contact:
        • Principal Investigator:
          • Carla Kurkjian, MD
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates of York
        • Principal Investigator:
          • Chanh Huynh, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Utah Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Kyle Kitchen, Pharm-D
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington / Fred Hutchinson Cancer Center
        • Principal Investigator:
          • Stacey Cohen, MD
        • Contact:
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Principal Investigator:
          • Matthias Weiss, MD, PhD
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This protocol targets patients with colorectal cancer (CRC), stage I-IVA disease

Description

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

Exclusion Criteria:

  • Not willing to have additional blood samples collected
  • Pathology that is not consistent with colorectal adenocarcinoma

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
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.
Other: Observation
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival
Time Frame: 2 years
Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 2 years
Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.
2 years
Positive Predictive Value
Time Frame: 2 years
Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.
2 years
Specificity
Time Frame: 2 years
Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead Time
Time Frame: 2 years
Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.
2 years
Overall Survival
Time Frame: 2 years or until the patient is reported deceased
The duration of time between enrollment and death for any reason
2 years or until the patient is reported deceased

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, 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)

June 21, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-CA-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Subscribe