ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Condition(s) studied
Investigational drug(s) / intervention(s)
Guardant Reveal: Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Study 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.
Eligibility
Primary outcome measure(s)
- Distant Recurrence Free Interval (D-RFi) — 3 years
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.
Trial sites (57)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Ironwood Cancer & Research Centers | Chandler | Arizona | Recruiting |
| Genesis Cancer Center | Hot Springs | Arkansas | Terminated |
| University of California, San Diego | La Jolla | California | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Recruiting |
| Redwood City | Redwood City | California | Recruiting |
| Sutter Institute for Medical Research | Sacramento | California | Terminated |
| University of Colorado | Aurora | Colorado | Recruiting |
| Memorial Healthcare System | Hollywood | Florida | Recruiting |
| The Oncology Institute of Hope & Innovation | Lakeland | Florida | Recruiting |
| Tulane Cancer Center | New Orleans | Louisiana | Recruiting |
| Christus Highland/ Boniol | Shreveport | Louisiana | Recruiting |
| Central Maine Medical Center | Lewiston | Maine | Terminated |
| Massachusetts General Hospital | Boston | Massachusetts | Terminated |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | Recruiting |
| Mayo Clinic (Rochester) | Rochester | Minnesota | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Terminated |
| UNC- Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | Terminated |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Toledo Clinic Cancer Center | Toledo | Ohio | Recruiting |
| Crozer-Keystone Health System | Broomall | Pennsylvania | Terminated |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| WellSpan Medical Oncology & Hematology at York Cancer Center | York | Pennsylvania | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | Recruiting |
| Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina | Terminated |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| DHR Health Advance Care Center | Edinburg | Texas | Recruiting |
| The Center for Cancer and Blood Disorders | Forth Worth | Texas | Recruiting |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | Recruiting |
| Utah Cancer Specialists | Salt Lake City | Utah | Recruiting |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | Recruiting |
| CHU Besançon | Besançon | France | Recruiting |
| Hôpital Franco-Britannique | Levallois-Perret | France | Recruiting |
| Institut Paoli-Calmettes | Marseille | France | Recruiting |
| Ambroise Paré-Hartmann | Neuilly | France | Recruiting |
| APHP Tenon Hospital - Sorbonne | Paris | France | Recruiting |
| Asklepios Klinik Altona | Hamburg | Germany | Recruiting |
| SLK-Kliniken Heilbronn GmbH | Heilbronn | Germany | Recruiting |
+ 17 more sites — see the full list on the official registry below.
More Guardant Health, Inc. trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05059444 on ClinicalTrials.gov ↗ ← All trials in France