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Recruiting NCT05935384

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

— Observational Non-small Cell Lung Cancer Colorectal Cancer Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guardant360.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer, Colorectal Cancer, Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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]
Secondary outcome measures (3)
  • RECIST Response [Time frame: 6 years]
  • Progression-Free Survival (PFS) [Time frame: 6 years]
  • Lead Time [Time frame: 6 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Orchard Healthcare Research Inc. — Skokie

Identifiers

NCT: NCT05935384 · 06-MX-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗