SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
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.
∙ Each participant must satisfy all the following criteria to be enrolled in the study:
• 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
• Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
• Are willing to provide blood samples at enrollment and at subsequent clinical visits
• Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:
‣ Cohort 1: Unresectable Stage III/IV NSCLC (\
∙ 125)
⁃ Cohort 2: Stage IV Colorectal (\
∙ 125)
⁃ Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\
⁃ Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\
⁃ Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.