SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Last updated: November 17, 2023
Sponsor: Guardant Health, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Breast Cancer

Colon Cancer

Treatment

Guardant360

Clinical Study ID

NCT05935384
06-MX-001
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

  • Will be treated with a first- or second-line systemic and/or oral standard of careregimen at the enrolling site
  • Patient is either treatment naive and has not yet commenced first line SOC therapy ORpatient has completed a prior line of SOC therapy and will commence subsequent line ofSOC therapy
  • Provide written informed consent to participate in the study
  • Diagnosed with an unresectable advanced solid malignancy and have a histologicallyconfirmed cancer that qualifies for inclusion, defined as:
  • Non-small cell lung cancer (stage III-IV)
  • Colorectal adenocarcinoma (stage III-IV)
  • Breast Cancer (stage III-IV)

Exclusion

Exclusion Criteria:

  • History of a prior solid or hematological malignancy within 5 years of enrollment
  • Life expectancy < 12 weeks
  • Unable to collect baseline blood sample prior to starting SOC regimen
  • Is participating in an interventional clinical trial or another observational studythat is evaluating the performance of another genomic test for detecting/predictingclinical response/progression

Study Design

Total Participants: 440
Treatment Group(s): 1
Primary Treatment: Guardant360
Phase:
Study Start date:
October 25, 2023
Estimated Completion Date:
August 30, 2029

Connect with a study center

  • Orchard Healthcare Research Inc.

    Skokie, Illinois 60077-1384
    United States

    Active - Recruiting

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