Trials / Recruiting
RecruitingNCT05059444
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,020 (estimated)
- Sponsor
- Guardant Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Bladder Carcinoma
- Ureter Carcinoma
- Renal Pelvis Carcinoma
- Non-small Cell Lung Cancer
- Invasive Breast Carcinoma
- Cutaneous Melanoma
- Esophageal Carcinoma
- Gastroesophageal Junction Carcinoma
- Gastric Adenocarcinoma
- Pancreatic Adenocarcinoma
- Squamous Cell Carcinoma of the Head and Neck
- Epithelial Ovarian Carcinoma
- Fallopian Tube Carcinoma
- Endometrial Carcinoma
- Renal Cell Carcinoma
- Rectal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Guardant Reveal | Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors. |
Timeline
- Start date
- 2021-09-07
- Primary completion
- 2029-08-01
- Completion
- 2029-08-01
- First posted
- 2021-09-28
- Last updated
- 2025-08-22
Locations
57 sites across 5 countries: United States, France, Germany, Italy, Spain
Source: ClinicalTrials.gov record NCT05059444. Inclusion in this directory is not an endorsement.