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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation | Clinical Trials | Clareo Health

RECRUITING

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

NCT05059444•Guardant Health, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age \> 18 years old AND
•Initial treatment is given with curative/radical intent AND
•Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND
•Provided written informed consent to participate in the study AND
•Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND
•Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND
•Have at least one Landmark blood sample
•Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:
•Primary Study Cohorts
•Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),
+14 more criteria

Exclusion Criteria

•History of allogeneic organ or tissue transplant
•Index cancer has predominantly neuroendocrine histology
•History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers, and stage I papillary thyroid carcinoma, and participants with bilateral/multifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment
•Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)

Locations (57)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Genesis Cancer Center

Hot Springs, Arkansas, United States

University of California, San Diego

La Jolla, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Redwood City

Redwood City, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

University of Colorado

Aurora, Colorado, United States

Memorial Healthcare System

Hollywood, Florida, United States

The Oncology Institute of Hope & Innovation

Lakeland, Florida, United States

Key Dates

Start Date

September 7, 2021

Primary Completion Date

August 1, 2029

Completion Date

August 1, 2029

Last Updated

August 22, 2025

Enrollment

2,020

ESTIMATED participants

Conditions

Bladder CarcinomaUreter CarcinomaRenal Pelvis CarcinomaNon-small Cell Lung CancerInvasive Breast CarcinomaCutaneous MelanomaEsophageal CarcinomaGastroesophageal Junction CarcinomaGastric AdenocarcinomaPancreatic AdenocarcinomaSquamous Cell Carcinoma of the Head and NeckEpithelial Ovarian CarcinomaFallopian Tube CarcinomaEndometrial CarcinomaRenal Cell CarcinomaRectal Adenocarcinoma

Interventions

Guardant Reveal

DIAGNOSTIC_TEST

Contacts

Clinical Trial Operations

CONTACT

8556988887 mrdoraclestudy@guardanthealth.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Inclusion Criteria

Exclusion Criteria

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer

Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study

Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease