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NCT Number: NCT05234177

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

Recruiting

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mercy Clinic Oncology - Fort Smith, Fort Smith, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

No intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. Sensitivity

    Time frame: 2 years

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

  2. Specificity

    Time frame: 2 years

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

  3. Positive Predictive Value

    Time frame: 2 years

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

Other outcomes

  1. 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. Lead Time

    Time frame: 2 years

    Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.

Study contacts

Contact information is provided by the study sponsor or research team.

CRC Surveillance Study

CONTACT

[email protected]

(833) 514-4187

Sponsors and collaborators

Lead sponsor

Tempus AI

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Feb 10, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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