TEMPUS ARIES: A Biobank Registry Platform Study in Oncology
ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorTempus AI
About this trial
This study is a non-interventional, multicenter, multicohort evaluation of participants with cancer who will undergo longitudinal plasma ctDNA biomarker profiling at specific time points in addition to standard of care therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
Willing to participate in the research
Able to provide informed consent
Must be diagnosed with cancer
Disqualifiers
None
Trial population
Participants diagnosed with cancer willing to have additional blood samples collected for ctDNA research.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 7 trial groups7
Trial groupsSee each trial group below.
Group A: Cohort 001: KRAS mutated CRC
Group B: Cohort 002: KRAS mutated PDAC
Group C: Cohort 003: KRAS mutated NSCLC
Group D: Cohort 004: Gastric 1L Plus
Group E: Cohort 005: mCRPC 1L Plus
Group F: Cohort 006: Pan Tumor ADCs
Group G: Cohort 007: Stage III-IV EGFR Activating Mutation NSCLC
Trial outcomes
Primary outcomes
1
Changes in ctDNA from baseline, on-treatment and post-treatment blood samples.
Assess ctDNA kinetics using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, and time to ctDNA recurrence and correlate with standard of care therapy real-world outcomes such as overall survival, progression-free survival, time to next treatment, and time to treatment discontinuation.
Time frame
5 yearsSecondary outcomes
1
Generation of DNA, RNA, immune and other multiomic datasets.
Use blood and tissue based next generation sequencing to uncover biomarkers that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.
Time frame
5 years Source ClinicalTrials.gov