ORACLE Study Evaluating Guardant Reveal Blood Test to Detect Cancer Return in Adults With Early-Stage Solid Tumors

What this Trial Is About

Researchers are evaluating the ability of a new blood test called Guardant Reveal, developed by Guardant Health, to detect cancer recurrence in people treated for early-stage solid tumors. This observational study aims to link the blood test results with clinical outcomes to show its potential value in monitoring cancer recurrence while considering healthcare costs. The study includes multiple types of cancers such as bladder, lung, breast, melanoma, esophageal, gastric, pancreatic, head and neck, ovarian, endometrial, renal, and rectal cancers. Participants are grouped into different cohorts based on their specific cancer type and stage, including muscle invasive carcinoma, non-small cell lung cancer, various types of breast cancer, melanoma, esophageal, gastric, pancreatic adenocarcinoma, head and neck squamous cell carcinoma, ovarian or fallopian tube carcinoma, endometrial carcinoma, renal cell carcinoma, and rectal adenocarcinoma. The study involves regular blood sample collection using the Guardant Reveal assay at enrollment and during routine medical visits, with follow-up lasting up to 5 years for ongoing monitoring of minimal residual disease and recurrence detection. During the study, participants will provide blood samples at scheduled visits aligned with their regular cancer care follow-up. Researchers will assess outcomes including the time without distant cancer recurrence over 3 years, along with test sensitivity, positive predictive value, and lead time for recurrence detection. Clinical data will be collected and shared anonymously with investigators, and participants will be monitored according to standard care practices throughout the study duration, which may extend up to 5 years or until the study ends in 2029.

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation