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NCT05059444Recruiting

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Guardant Health, Inc.

Start Date

9/7/2021

Completion Date

8/1/2029

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 Criteria

Age Range: 18 years to No maximum

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), * Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III): Cohort 2A: Resectable OR Cohort 2B: Unresectable, * Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following: Cohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive/HER2-negative invasive breast carcinoma, * Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent, * Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III), * Cohort 6: Gastric adenocarcinoma (stage II-III), * Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection, * Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus cancers), * Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology), * Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III), * Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent) Exploratory Cohort * Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen 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)

Interventions

DIAGNOSTIC_TEST

Guardant Reveal

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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

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35205

United States

Ironwood Cancer & Research Centers

Chandler, Arizona 85224

United States

Genesis Cancer Center

Hot Springs, Arkansas 71913

United States

University of California, San Diego

La Jolla, California 92093

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

Redwood City

Redwood City, California 94063

United States

Sutter Institute for Medical Research

Sacramento, California 95816

United States

University of Colorado

Aurora, Colorado 80045

United States

Memorial Healthcare System

Hollywood, Florida 33021

United States

The Oncology Institute of Hope & Innovation

Lakeland, Florida 33812

United States

Tulane Cancer Center

New Orleans, Louisiana 70112

United States

Christus Highland/ Boniol

Shreveport, Louisiana 71105

United States

Central Maine Medical Center

Lewiston, Maine 04240

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan 49503

United States

Mayo Clinic (Rochester)

Rochester, Minnesota 55905

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

UNC- Chapel Hill

Chapel Hill, North Carolina 27599

United States

The Christ Hospital Cancer Center

Cincinnati, Ohio 45219

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Toledo Clinic Cancer Center

Toledo, Ohio 43623

United States

Crozer-Keystone Health System

Broomall, Pennsylvania 19008

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Cancer Care Associates of York

York, Pennsylvania 17403

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina 29732

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

DHR Health Advance Care Center

Edinburg, Texas 78539

United States

The Center for Cancer and Blood Disorders

Forth Worth, Texas 76104

United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States

Utah Cancer Specialists

Salt Lake City, Utah 84106

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin 54911

United States

CHU Besançon

Besançon, 25000

France

Hôpital Franco-Britannique

Levallois-Perret, 92300

France

Institut Paoli-Calmettes

Marseille, 13009

France

Ambroise Paré-Hartmann

Neuilly, 92200

France

APHP Tenon Hospital - Sorbonne

Paris, 75020

France

Asklepios Klinik Altona

Hamburg, 22763

Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, 74078

Germany

Ludwig Maximilian University Munich

Munich, 81377

Germany

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

Meldola, 47014

Italy

Azienda USL-IRCCS di Reggio Emilia

Reggio Emilia, 42123

Italy

Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

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

A Coruña, 15006

Spain

Vall Hebron Institute of Oncology

Barcelona, 08035

Spain

Hospital Clinic of Barcelona

Barcelona, 08036

Spain

ICO Institut Catala d'Oncologia

Barcelona, 08908

Spain

Instituto Catalan de Oncologia de Girona

Girona, 17007

Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria,

Spain

Hospital San Carlos

Madrid, 28040

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

CIOSS HM Sanchinarro

Madrid, 28050

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

CCS Hospital Universitari Parc Taulí

Sabadell, 08208

Spain

Hospital Clinico de Santiago de Compostela

Santiago de Compostela, 15706

Spain

Hospital Clínico de Valencia

Valencia, 46010

Spain