Study

ORACLE: Observation of ResiduAl Cancer with Liquid Biopsy Evaluation

To measure distant recurrence free interval from end of treatment stratified by landmark (4-12 weeks post-treatment) and serial post-treatment ctDNA detection status (detected vs. not detected). 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.

Why this Research Matters

This study plans to learn more about if a blood test can predict whether cancer will recur (come back) after initial treatment. In some cases, cancer is cured after initial treatment, but in other cases, cancer cells remain in the body. These remaining cancer cells can grow over time. If not treated or caught in time, they may become incurable. Today, doctors are not usually able to accurately predict which cancers will come back and which ones are already cured. This leads to uncertainty about the best way to treat the person’s cancer. In addition, cancer recurrences are often caught too late using tests available today. The Sponsor of this research, Guardant Health, has developed a blood test to detect remaining cancer cells. We believe this test could help detect recurrent cancer earlier and more accurately than other tests available today. This research will test just how accurate the Guardant Health test is. It is our hope that this test could one day help personalize cancer treatment options, provide better information about how well cancer treatment worked, and better detect early signs of cancer coming back when it may still be curable. This test is investigational. “Investigational” means that the study test has not been approved by the U.S. Food and Drug Administration (FDA). You are being asked to be in this research study because you were treated for cancer.

Who can Participate

Adult

- treated with curative intent - planning to undergo regular follow up and monitoring for cancer recurrence per standard of care at the enrolling site patients must have either: - Esophageal or gastroesophageal junction carcinoma (stage II-III) or - Gastric adenocarcinoma (stage II-III) or - Surgically resected pancreatic adenocarcinoma Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov