SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuardant Health, Inc.
About this trial
The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.
Eligibility criteria
Qualifiers
Age ≥18 years old
Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy
Able to understand, and capable of providing written consent to participate in the study
Disqualifiers
History of prior solid malignancy or hematological malignancy within five years of enrollment
Life expectancy ≤12 weeks
Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen
Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression
Trial design
Treatments tested in this trial
- Guardant360
Treatment groups
470 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov