NCT05935384 · Guardant Health, Inc.
SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Guardant360
Guardant360 is a qualitative next generation sequencing (NGS)-based in vitro diagnostic device for detection of single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions in genes frequently mutated in cancer, using circulating cell-free DNA (cfDNA) obtained from the plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes.
Primary outcome measures
Sensitivity of ctDNA to Detect Disease Progression
Time frame: 6 years
The Primary Endpoint, sensitivity of ctDNA to detect disease progression, will be evaluated from all eligible subjects within the primary study cohorts (breast cancer, NSCLC, or CRC)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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- (\~55)
- Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55)
- Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55)
- Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.
Exclusion criteria
- Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:
- 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
Where
- Skokie, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 22, 2025 · Source of record for eligibility and locations