RecruitingNCT05059444

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Sponsor

Guardant Health, Inc.

Enrollment

2,020 participants

Start Date

Sep 7, 2021

Study Type

OBSERVATIONAL

Conditions

Bladder Carcinoma Esophageal Carcinoma Non-small Cell Lung Cancer Renal Cell Carcinoma Invasive Breast Carcinoma Ureter Carcinoma Renal Pelvis Carcinoma Cutaneous Melanoma Gastroesophageal Junction Carcinoma Gastric Adenocarcinoma Pancreatic Adenocarcinoma Squamous Cell Carcinoma of the Head and Neck Epithelial Ovarian Carcinoma Fallopian Tube Carcinoma Endometrial Carcinoma Rectal Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study (called ORACLE) follows cancer survivors after they've completed treatment to see if a blood-based test (liquid biopsy) that detects tiny fragments of cancer DNA can catch a relapse earlier than standard scans and follow-up. No experimental treatment is given — the study only collects blood samples alongside your normal care. **You may be eligible if...** - You are 18 or older and were treated for cancer with the intent to cure - You have one of several cancer types including bladder cancer, non-small cell lung cancer, breast cancer, colon/rectal cancer, pancreatic cancer, kidney cancer, ovarian cancer, cervical cancer, endometrial cancer, or head and neck cancer - You are willing to provide blood samples at regular clinic visits for up to 5 years **You may NOT be eligible if...** - Your cancer was not treated with curative intent - You are unwilling to share anonymized clinical data with researchers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTGuardant Reveal

Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.

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

Tulane Cancer Center

New Orleans, Louisiana, United States

Christus Highland/ Boniol

Shreveport, Louisiana, United States

Central Maine Medical Center

Lewiston, Maine, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Mayo Clinic (Rochester)

Rochester, Minnesota, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

UNC- Chapel Hill

Chapel Hill, North Carolina, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Toledo Clinic Cancer Center

Toledo, Ohio, United States

Crozer-Keystone Health System

Broomall, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Cancer Care Associates of York

York, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

DHR Health Advance Care Center

Edinburg, Texas, United States

The Center for Cancer and Blood Disorders

Forth Worth, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

CHU Besançon

Besançon, France

Hôpital Franco-Britannique

Levallois-Perret, France

Institut Paoli-Calmettes

Marseille, France

Ambroise Paré-Hartmann

Neuilly, France

APHP Tenon Hospital - Sorbonne

Paris, France

Asklepios Klinik Altona

Hamburg, Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, Germany

Ludwig Maximilian University Munich

Munich, Germany

Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST, SrL

Meldola, Italy

Azienda USL-IRCCS di Reggio Emilia

Reggio Emilia, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Hospital Teresa Herrera (C.H.U.A.C)

A Coruña, Spain

Vall Hebron Institute of Oncology

Barcelona, Spain

Hospital Clinic of Barcelona

Barcelona, Spain

ICO Institut Catala d'Oncologia

Barcelona, Spain

Instituto Catalan de Oncologia de Girona

Girona, Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Hospital San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

CIOSS HM Sanchinarro

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

CCS Hospital Universitari Parc Taulí

Sabadell, Spain

Hospital Clinico de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Clínico de Valencia

Valencia, Spain

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NCT05059444

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