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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05234177

Enrollment

300

Registered

2022-02-10

Start date

2022-06-21

Completion date

2029-02-28

Last updated

2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

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

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.

Interventions

OTHERObservation

No intervention

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Recurrence-Free Survival	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

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

Other

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

Countries

United States

Contacts

Primary ContactCRC Surveillance Study

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026