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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
NCT05059444 · Guardant Health, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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)
Study design
Enrollment target: 2020 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-09-07
Estimated completion: 2029-08
Last updated: 2025-08-22
Interventions
Diagnostic Test: Guardant Reveal
Primary outcomes
- • Distant Recurrence Free Interval (D-RFi) (3 years)
Sponsor
Guardant Health, Inc. · industry
Contacts & investigators
ContactClinical Trial Operations · contact · mrdoraclestudy@guardanthealth.com · 8556988887
InvestigatorStudy Director · study_director, Guardant Health, Inc.
All locations (57)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Ironwood Cancer & Research CentersRecruiting
Chandler, Arizona, United States
Genesis Cancer CenterTerminated
Hot Springs, Arkansas, United States
University of California, San DiegoRecruiting
La Jolla, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
Redwood CityRecruiting
Redwood City, California, United States
Sutter Institute for Medical ResearchTerminated
Sacramento, California, United States
University of ColoradoRecruiting
Aurora, Colorado, United States
Memorial Healthcare SystemRecruiting
Hollywood, Florida, United States
The Oncology Institute of Hope & InnovationRecruiting
Lakeland, Florida, United States
Tulane Cancer CenterRecruiting
New Orleans, Louisiana, United States
Christus Highland/ BoniolRecruiting
Shreveport, Louisiana, United States
Central Maine Medical CenterRecruiting
Lewiston, Maine, United States
Massachusetts General HospitalTerminated
Boston, Massachusetts, United States
Cancer & Hematology Centers of Western MichiganRecruiting
Grand Rapids, Michigan, United States
Mayo Clinic (Rochester)Recruiting
Rochester, Minnesota, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
Icahn School of Medicine at Mount SinaiTerminated
New York, New York, United States
UNC- Chapel HillRecruiting
Chapel Hill, North Carolina, United States
The Christ Hospital Cancer CenterTerminated
Cincinnati, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Toledo Clinic Cancer CenterRecruiting
Toledo, Ohio, United States
Crozer-Keystone Health SystemTerminated
Broomall, Pennsylvania, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Cancer Care Associates of YorkRecruiting
York, Pennsylvania, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Carolina Blood and Cancer Care AssociatesRecruiting
Rock Hill, South Carolina, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
DHR Health Advance Care CenterRecruiting
Edinburg, Texas, United States
The Center for Cancer and Blood DisordersRecruiting
Forth Worth, Texas, United States
The University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
Utah Cancer SpecialistsRecruiting
Salt Lake City, Utah, United States
ThedaCare Regional Cancer CenterRecruiting
Appleton, Wisconsin, United States
CHU BesançonRecruiting
Besançon, France
Hôpital Franco-BritanniqueRecruiting
Levallois-Perret, France
Institut Paoli-CalmettesRecruiting
Marseille, France
Ambroise Paré-HartmannRecruiting
Neuilly, France
APHP Tenon Hospital - SorbonneRecruiting
Paris, France
Asklepios Klinik AltonaRecruiting
Hamburg, Germany
SLK-Kliniken Heilbronn GmbHRecruiting
Heilbronn, Germany
Ludwig Maximilian University MunichRecruiting
Munich, Germany
Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST, SrLRecruiting
Meldola, Italy
Azienda USL-IRCCS di Reggio EmiliaRecruiting
Reggio Emilia, Italy
Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
Hospital Teresa Herrera (C.H.U.A.C)Recruiting
A Coruña, Spain
Vall Hebron Institute of OncologyRecruiting
Barcelona, Spain
Hospital Clinic of BarcelonaRecruiting
Barcelona, Spain
ICO Institut Catala d'OncologiaRecruiting
Barcelona, Spain
Instituto Catalan de Oncologia de GironaRecruiting
Girona, Spain
Hospital Universitario Insular de Gran CanariaRecruiting
Las Palmas de Gran Canaria, Spain
Hospital San CarlosRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
CIOSS HM SanchinarroRecruiting
Madrid, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
CCS Hospital Universitari Parc TaulíRecruiting
Sabadell, Spain
Hospital Clinico de Santiago de CompostelaRecruiting
Santiago de Compostela, Spain
Hospital Clínico de ValenciaRecruiting
Valencia, Spain