Observing therapy response using liquid biopsy evaluation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SIBYL study aims to collect clinical data to validate the effectiveness of a future version of the Guardant360 test in measuring responses to systemic therapy in patients with unresectable advanced solid tumors. Participants will be treated with standard care regimens while their treatment outcomes and ctDNA dynamics will be monitored. The study will correlate these dynamics with traditional evaluation methods such as RECIST 1.1 and CT scans to assess therapeutic response.

Why it matters

Who can join: the full rules

Inclusion Criteria

Each participant must satisfy all the following criteria to be enrolled in the study:

1. Age ≥18 years old
2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
3. 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
4. Able to understand, and capable of providing written consent to participate in the study
5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
6. Are willing to provide blood samples at enrollment and at subsequent clinical visits
7. 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:

1. History of prior solid malignancy or hematological malignancy within five years of enrollment
2. Life expectancy ≤12 weeks
3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen
4. 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 it's running

• Orchard Healthcare Research Inc.
  Skokie, Illinois, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Operations
• Email: sibyl@guardanthealth.com
• Phone: 8556988887

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.