ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Summary
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.
Arms & interventions
- Diagnostic TestGuardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Outcome measures
Primary
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
Secondary
Sensitivity
Time frame: 3 years
Positive Predictive Value
Time frame: 3 years
Lead Time
Time frame: 3 years
Eligibility criteria
Study locations (33)
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Genesis Cancer Center
Hot Springs, Arkansas, 71913
University of California, San Diego
La Jolla, California, 92093
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Redwood City
Redwood City, California, 94063
Sutter Institute for Medical Research
Sacramento, California, 95816
University of Colorado
Aurora, Colorado, 80045
Memorial Healthcare System
Hollywood, Florida, 33021
The Oncology Institute of Hope & Innovation
Lakeland, Florida, 33812
Tulane Cancer Center
New Orleans, Louisiana, 70112
Christus Highland/ Boniol
Shreveport, Louisiana, 71105
Central Maine Medical Center
Lewiston, Maine, 04240
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Mayo Clinic (Rochester)
Rochester, Minnesota, 55905
Astera Cancer Care
East Brunswick, New Jersey, 08816
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
UNC- Chapel Hill
Chapel Hill, North Carolina, 27599
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
Crozer-Keystone Health System
Broomall, Pennsylvania, 19008
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Cancer Care Associates of York
York, Pennsylvania, 17403
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
UT Southwestern Medical Center
Dallas, Texas, 75390
DHR Health Advance Care Center
Edinburg, Texas, 78539
The Center for Cancer and Blood Disorders
Forth Worth, Texas, 76104
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Utah Cancer Specialists
Salt Lake City, Utah, 84106
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911