SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Plain-language summary

This study evaluates whether response to cancer treatment can be monitored using a liquid biopsy blood test called Guardant360. It enrolls patients aged 18 and older with advanced cancers such as non-small cell lung cancer, colorectal cancer, and breast cancer, with blood samples collected at regular intervals. It is an observational (no assigned phase) study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Guardant Health, Inc.

Intervention

Guardant360

Start date

10/25/2023

Estimated completion

12/30/2030

Countries

United States

Related genes

Locations

• Skokie, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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