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NCT05059444 · ClinicalTrials.gov registry record
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
A clinical trial of Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma, sponsored by Guardant Health.
- Recruiting
- Registry status
- 2,020
- Enrollment target
- 20
- Study locations
NCT05059444: Recruiting study of Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma, sponsored by Guardant Health.
NCT05059444 is a study of Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma that is actively recruiting participants, run by Guardant Health. The registered enrollment target is 2,020 participants, above the 648-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (212% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05059444, a study of Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma, is actively recruiting participants, sponsored by Guardant Health.
- RECRUITING
- Registry status
- 2,020 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
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 |
What NCT05059444 shows while recruiting
NCT05059444 is an observational study that tracks outcomes without assigning an intervention. Its 2,020 participants enrollment target places it among the larger protocols in the corpus, above the 648-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (212% higher).
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.
NCT05059444 names 20 study sites across 15 states, led by California, Florida, Louisiana.
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.
What interventions are being tested in trial NCT05059444?
The interventions under investigation include: Guardant Reveal (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05059444?
This trial is sponsored by Guardant Health, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05059444's enrollment target sits among peer trials
2,020 7th of 454 higher than 448 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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