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Colorectal CancerNCT05234177

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

An observational study of Colorectal Cancer, run by Tempus AI at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Observation
Type of treatment
Injection or infusion
How many people
300 participants
Where
20 sitesUnited States
Study dates
21 Jun 2022to Feb 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

CRC Surveillance Study contact

(833) 514-4187

gemini-crc@tempus.com

20 sites in 1 country

United States20 sites, 20 recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

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

    Matthias Weiss, MD, PhD

    Recruiting

  • The Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

    Kosunique Jenkins, 301-571-2016, kosunique.jenkins@tempus.com

    Mark Goldstein, MD

    Recruiting

  • Aultman Hospital

    Canton, Ohio, 44710

    Kristin Shine, Kristin.Shine@aultman.com

    Adarsh Vennepureddy, MD

    Recruiting

  • TriHealth Cancer Institute

    Cincinnati, Ohio, 45220

    Wayne Thompson, 513-865-5020, Wayne_Thompson@trihealth.com

    Benjamin Kuritzky, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Jennifer Moon, jennifer.moon@osumc.edu

    Arjun Mittra, MD

    Recruiting

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

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

    Arvinder Bhinder, MD

    Recruiting

  • Mercy Clinic Oncology - Fort Smith

    Fort Smith, Arkansas, 72903

    Billy Cater, Billy.Cater@mercy.net

    Aswanth Reddy, MD

    Recruiting

  • MemorialCare

    Fountain Valley, California, 92708

    Laura Macias, 562.706.2701, LMacias@memorialcare.org

    Amol Rao, MD

    Recruiting

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27543

    Jennifer Fields, 919-587-9084, jfields@cancersmoc.com

    Samer Kasbari, MD

    Recruiting

  • Mercy Clinic Oncology and Hematology - Joplin

    Joplin, Missouri, 64804

    Cynthia Meyer, Cynthia.Meyer@mercy.net

    Samir Dalia, MD

    Recruiting

  • Mercy Clinic Oncology and Hematology - Coletta

    Oklahoma City, Oklahoma, 73120

    Patricia Strubhar, Patricia.Strubhar@mercy.net

    Carla Kurkjian, MD

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Brenda Broekemeier, 308-218-6324, bbroekemeier@nebraskacancer.com

    Timothy Huyck, MD

    Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84124

    Angela Nuttall, 801-267-5606, anuttall@utahcancer.com

    Kyle Kitchen, Pharm-D

    Recruiting

  • University of Washington / Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Bentina Marin, amarin@fredhutch.org

    Stacey Cohen, MD

    Recruiting

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

    Springfield, Missouri, 65804

    Jennifer Hylton, Jennifer.Hylton@mercy.net

    Mohan Tummala, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Mary Pecoraro, 314-273-0884, mpecoraro@wustl.edu

    Ryan Fields, MD

    Recruiting

  • Mercy Clinic Oncology and Hematology - Sindelar Cancer Center

    St Louis, Missouri, 63128

    Jessica Black, Jessica.Black@mercy.net

    Yifan Tu, MD

    Recruiting

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

    St Louis, Missouri, 63141

    Emily Hoven, Emily.Hoven@Mercy.Net

    Bethany Sleckman, MD

    Recruiting

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

    Pam Shoup, 419-214-4236, pshoup@toledoclinic.com

    John Nemunaitis, MD

    Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

    Jennifer Stough, 717-741-9229, jstough@cancercareyork.com

    Chanh Huynh, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Observation
Keywords
Cancer, Oncology, Observational, Genomic Profiling, Precision medicine, CRC, Colorectal Cancer, NGS, Biomarkers
Medical subject headings
Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

    No intervention

Study groups in NCT05234177
Study groupRoleWhat they receive
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.
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-Free Survival

    Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death

    Measured: 2 years

Secondary outcomes (3)

  1. Sensitivity

    Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.

    Measured: 2 years

  2. Specificity

    Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected.

    Measured: 2 years

  3. Positive Predictive Value

    Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start21 Jun 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234177
Sponsor's protocol ID
TP-CA-004
Status last verified
May 2025
First submitted
31 Jan 2022
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.

    PubMed 30620402

  • Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5.

    PubMed 32133645

  • Stoffel EM, Murphy CC. Epidemiology and Mechanisms of the Increasing Incidence of Colon and Rectal Cancers in Young Adults. Gastroenterology. 2020 Jan;158(2):341-353. doi: 10.1053/j.gastro.2019.07.055. Epub 2019 Aug 5.

    PubMed 31394082

  • Islami F, Ward EM, Sung H, Cronin KA, Tangka FKL, Sherman RL, Zhao J, Anderson RN, Henley SJ, Yabroff KR, Jemal A, Benard VB. Annual Report to the Nation on the Status of Cancer, Part 1: National Cancer Statistics. J Natl Cancer Inst. 2021 Nov 29;113(12):1648-1669. doi: 10.1093/jnci/djab131.

    PubMed 34240195

  • Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.

    PubMed 24225001

  • Institute NC, National Cancer Institute. AJCC Cancer Staging Manual 8th Edition. Definitions. 2020

  • Leufkens AM, van den Bosch MA, van Leeuwen MS, Siersema PD. Diagnostic accuracy of computed tomography for colon cancer staging: a systematic review. Scand J Gastroenterol. 2011 Jul;46(7-8):887-94. doi: 10.3109/00365521.2011.574732. Epub 2011 Apr 20.

    PubMed 21504379

  • Benson AB 3rd, Choti MA, Cohen AM, Doroshow JH, Fuchs C, Kiel K, Martin EW Jr, McGinn C, Petrelli NJ, Posey JA, Skibber JM, Venook A, Yeatman TJ; National Comprehensive Cancer Network. NCCN Practice Guidelines for Colorectal Cancer. Oncology (Williston Park). 2000 Nov;14(11A):203-12.

    PubMed 11195411

  • Kahi CJ, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Robertson DJ, Rex DK; United States Multi-Society Task Force on Colorectal Cancer. Colonoscopy Surveillance After Colorectal Cancer Resection: Recommendations of the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2016 Mar;150(3):758-768.e11. doi: 10.1053/j.gastro.2016.01.001. Epub 2016 Feb 10.

    PubMed 26892199

  • Winawer SJ, Fletcher RH, Miller L, Godlee F, Stolar MH, Mulrow CD, Woolf SH, Glick SN, Ganiats TG, Bond JH, Rosen L, Zapka JG, Olsen SJ, Giardiello FM, Sisk JE, Van Antwerp R, Brown-Davis C, Marciniak DA, Mayer RJ. Colorectal cancer screening: clinical guidelines and rationale. Gastroenterology. 1997 Feb;112(2):594-642. doi: 10.1053/gast.1997.v112.agast970594. No abstract available.

    PubMed 9024315

  • Provenzale D, Ness RM, Llor X, Weiss JM, Abbadessa B, Cooper G, Early DS, Friedman M, Giardiello FM, Glaser K, Gurudu S, Halverson AL, Issaka R, Jain R, Kanth P, Kidambi T, Lazenby AJ, Maguire L, Markowitz AJ, May FP, Mayer RJ, Mehta S, Patel S, Peter S, Stanich PP, Terdiman J, Keller J, Dwyer MA, Ogba N. NCCN Guidelines Insights: Colorectal Cancer Screening, Version 2.2020. J Natl Compr Canc Netw. 2020 Oct 1;18(10):1312-1320. doi: 10.6004/jnccn.2020.0048.

    PubMed 33022639

  • Ladabaum U, Dominitz JA, Kahi C, Schoen RE. Strategies for Colorectal Cancer Screening. Gastroenterology. 2020 Jan;158(2):418-432. doi: 10.1053/j.gastro.2019.06.043. Epub 2019 Aug 5.

    PubMed 31394083

  • Muller MF, Ibrahim AE, Arends MJ. Molecular pathological classification of colorectal cancer. Virchows Arch. 2016 Aug;469(2):125-34. doi: 10.1007/s00428-016-1956-3. Epub 2016 Jun 20.

    PubMed 27325016

  • Poulogiannis G, Ichimura K, Hamoudi RA, Luo F, Leung SY, Yuen ST, Harrison DJ, Wyllie AH, Arends MJ. Prognostic relevance of DNA copy number changes in colorectal cancer. J Pathol. 2010 Feb;220(3):338-47. doi: 10.1002/path.2640.

    PubMed 19911421

  • Arends MJ. Pathways of colorectal carcinogenesis. Appl Immunohistochem Mol Morphol. 2013 Mar;21(2):97-102. doi: 10.1097/PAI.0b013e31827ea79e.

    PubMed 23417071

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Tempus AI at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CRC Surveillance Study ((833) 514-4187, gemini-crc@tempus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05234177, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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