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

Tempus AI300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Colorectal Cancer

Interventions

ObservationOTHER

No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Mercy Clinic Oncology - Fort Smith

Fort Smith, Arkansas, United States

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Sensitivity

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

Time frame: 2 years

Specificity

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

Time frame: 2 years

Positive Predictive Value

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

Time frame: 2 years

Central Contacts

CRC Surveillance Study

CONTACT

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

Data from ClinicalTrials.gov

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