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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
NCT05059444 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Guardant Reveal
Study Locations (20)
California
- University of California, San Diego — La Jolla
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Redwood City — Redwood City
- Sutter Institute for Medical Research — Sacramento
Florida
- Memorial Healthcare System — Hollywood
- The Oncology Institute of Hope & Innovation — Lakeland
Louisiana
- Tulane Cancer Center — New Orleans
- Christus Highland/ Boniol — Shreveport
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- Ironwood Cancer & Research Centers — Chandler
Arkansas
- Genesis Cancer Center — Hot Springs
Colorado
- University of Colorado — Aurora
Maine
- Central Maine Medical Center — Lewiston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,020 participants |
| Start Date | 2021-09-07 |
| Est. Completion | 2029-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05059444
The ClinicalTrials.gov registry entry for NCT05059444 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,020 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guardant Health, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Guardant Reveal is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05059444 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05059444 about?
NCT05059444 is a clinical study titled "ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation". 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 recu...
What is the current status of trial NCT05059444?
This trial is currently recruiting. The enrollment target is 2,020 participants. The study started on 2021-09-07. Estimated completion is 2029-08.
What conditions does trial NCT05059444 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Invasive Breast Carcinoma, Cutaneous Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05059444?
The interventions under investigation include: Guardant Reveal (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05059444?
This trial is sponsored by Guardant Health, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05059444 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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