Life sciences · Observational Study
ClinicalTrials.gov · September 14, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT05059444). This is a study registration, not published results. Lead sponsor: Guardant Health, Inc.. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 2285 participants (ESTIMATED). 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, Colon Adenocarcinoma. Interventions: DIAGNOSTIC_TEST: Guardant Reveal. Primary outcome measures: Distant Recurrence Free Interval (D-RFi) , 3 years. Brief 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.