Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTempus AI
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not willing to have additional blood samples collected
Pathology that is not consistent with colorectal adenocarcinoma
Trial population
This protocol targets patients with colorectal cancer (CRC), stage I-IVA disease
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Observation
Other interventionNo intervention
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Participants with stage I-IV colorectal cancer (CRC)1 intervention
Trial outcomes
Primary outcomes
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
Time frame
2 yearsSecondary outcomes
1
Sensitivity
Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected.
Time frame
2 years2
Specificity
Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected.
Time frame
2 years3
Positive Predictive Value
Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur.
Time frame
2 yearsOther outcomes
1
Overall Survival
The duration of time between enrollment and death for any reason
Time frame
2 years or until the patient is reported deceased2
Lead Time
Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.
Time frame
2 years Source ClinicalTrials.gov