SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Part of paid clinical trials in Skokie, Illinois.

Sponsor
Guardant Health, Inc.
Study ID
NCT05935384
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guardant360 — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Oct 25, 2023
Status verified
Aug 2025
Primary completion
Dec 30, 2030
Completion
Dec 30, 2030

Study Design

Enrollment
470 participants (estimated)

Arms

  • Arm: Cohort 1: Unresectable Stage III/IV NSCLC
    Blood samples collected will be banked
  • Arm: Cohort 2: Stage IV Colorectal
    Blood samples collected will be banked
  • Arm: Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2-
    Blood samples collected will be banked
  • Arm: Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+
    Blood samples collected will be banked
  • Arm: Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+
    Blood samples collected will be banked
  • Arm: Cohort 6: Unresectable Stage III/IV Breast - Triple Negative
    Blood samples collected will be banked

Primary Outcome Measure

Sensitivity of ctDNA to Detect Disease Progression [ Time Frame: 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orchard Healthcare Research Inc.SkokieIllinois60077-1384
Ira Oliff

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By research site
Orchard Healthcare Research Inc.· Skokie, IL

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