Recruiting

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

Sponsor:

Tempus AI

Code:

NCT05234177

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observation

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Study ID

NCT05234177

Start date

Jun 21, 2022

Status verified date

May, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Observation

No intervention

Primary outcome measure

Recurrence-Free Survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

CRC Surveillance Study

(833) 514-4187 gemini-crc@tempus.com

Locations

Mercy Clinic Oncology - Fort Smith

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Billy Cater

Billy.Cater@mercy.net

Principal Investigator:

Aswanth Reddy, MD

MemorialCare

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Laura Macias

562.706.2701 LMacias@memorialcare.org

Principal Investigator:

Amol Rao, MD

The Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Kosunique Jenkins

301-571-2016 kosunique.jenkins@tempus.com

Principal Investigator:

Mark Goldstein, MD

Mercy Clinic Oncology and Hematology - Joplin

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Cynthia Meyer

Cynthia.Meyer@mercy.net

Principal Investigator:

Samir Dalia, MD

Washington University School of Medicine

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Mary Pecoraro

314-273-0884 mpecoraro@wustl.edu

Principal Investigator:

Ryan Fields, MD

Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

Recruiting

Saint Louis, Missouri, United States, 63128

Contacts

Jessica Black

Jessica.Black@mercy.net

Principal Investigator:

Yifan Tu, MD

Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

Recruiting

Saint Louis, Missouri, United States, 63141

Contacts

Emily Hoven

Emily.Hoven@Mercy.Net

Principal Investigator:

Bethany Sleckman, MD

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Jennifer Hylton

Jennifer.Hylton@mercy.net

Principal Investigator:

Mohan Tummala, MD

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Brenda Broekemeier

308-218-6324 bbroekemeier@nebraskacancer.com

Principal Investigator:

Timothy Huyck, MD

Southeastern Medical Oncology Center

Recruiting

Goldsboro, North Carolina, United States, 27543

Contacts

Jennifer Fields

919-587-9084 jfields@cancersmoc.com

Principal Investigator:

Samer Kasbari, MD

Aultman Hospital

Recruiting

Canton, Ohio, United States, 44710

Contacts

Kristin Shine

Kristin.Shine@aultman.com

Principal Investigator:

Adarsh Vennepureddy, MD

TriHealth Cancer Institute

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Wayne Thompson

513-865-5020 Wayne_Thompson@trihealth.com

Principal Investigator:

Benjamin Kuritzky, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jennifer Moon

jennifer.moon@osumc.edu

Principal Investigator:

Arjun Mittra, MD

OhioHealth Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Kevin Miller

614-788-3886 Kevin.Miller@ohiohealth.com

Principal Investigator:

Arvinder Bhinder, MD

Toledo Clinic Cancer Center

Recruiting

Toledo, Ohio, United States, 43623

Contacts

Pam Shoup

419-214-4236 pshoup@toledoclinic.com

Principal Investigator:

John Nemunaitis, MD

Mercy Clinic Oncology and Hematology - Coletta

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Patricia Strubhar

Patricia.Strubhar@mercy.net

Principal Investigator:

Carla Kurkjian, MD

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Jennifer Stough

717-741-9229 jstough@cancercareyork.com

Principal Investigator:

Chanh Huynh, MD

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

Angela Nuttall

801-267-5606 anuttall@utahcancer.com

Principal Investigator:

Kyle Kitchen, Pharm-D

University of Washington / Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Bentina Marin

amarin@fredhutch.org

Principal Investigator:

Stacey Cohen, MD

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Rachel Luedtke

920-364-3616 Rachel.Luedtke@thedacare.org

Principal Investigator:

Matthias Weiss, MD, PhD

More Information

Sponsor

Tempus AI

Last update posted

May 6, 2025

Last verified

May, 2025

Keywords

Cancer
Oncology
Observational
Genomic Profiling
Precision medicine
CRC
Colorectal Cancer
NGS
Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tempus AI on 2025-05-06.