The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.
Study Type
OBSERVATIONAL
Enrollment
2,020
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGIronwood Cancer & Research Centers
Chandler, Arizona, United States
RECRUITINGGenesis Cancer Center
Hot Springs, Arkansas, United States
TERMINATEDUniversity of California, San Diego
La Jolla, California, United States
Distant Recurrence Free Interval (D-RFi)
The primary endpoint, distant recurrence-free interval (D-RFi), will be evaluated for each of the primary study cohorts. D-RFi is defined as the time from the end of primary treatment until the time of diagnosis of a distant recurrence of the Index Cancer. Subjects without a distant recurrence will be censored at the time of last follow-up of their Index Cancer.
Time frame: 3 years
Sensitivity
Sensitivity defined as the proportion of participants who develop distant recurrence who have ctDNA detected at or before the time of clinical detection of recurrence.
Time frame: 3 years
Positive Predictive Value
Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected at the landmark or any surveillance timepoint who recur (either distally or locally).
Time frame: 3 years
Lead Time
Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.
Time frame: 3 years
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGRedwood City
Redwood City, California, United States
RECRUITINGSutter Institute for Medical Research
Sacramento, California, United States
TERMINATEDUniversity of Colorado
Aurora, Colorado, United States
RECRUITINGMemorial Healthcare System
Hollywood, Florida, United States
RECRUITINGThe Oncology Institute of Hope & Innovation
Lakeland, Florida, United States
RECRUITING...and 47 more locations