ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
ORACLE
1 other identifier
observational
2,020
5 countries
57
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2021
CompletedFirst Submitted
Initial submission to the registry
September 16, 2021
CompletedFirst Posted
Study publicly available on registry
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
August 22, 2025
August 1, 2025
7.9 years
September 16, 2021
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Distant Recurrence Free Interval (D-RFi)
The primary endpoint, distant recurrence-free interval (D-RFi), will be evaluated for each of the primary study cohorts. D-RFi is defined as the time from the end of primary treatment until the time of diagnosis of a distant recurrence of the Index Cancer. Subjects without a distant recurrence will be censored at the time of last follow-up of their Index Cancer.
3 years
Secondary Outcomes (3)
Sensitivity
3 years
Positive Predictive Value
3 years
Lead Time
3 years
Other Outcomes (8)
Recurrence-free interval (RFi)
3 years
Negative predictive value (NPV)
3 years
Association with resolution of indeterminate findings
3 years
- +5 more other outcomes
Study Arms (12)
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
Cohort 2: Non-small cell lung cancer (stage IB-III)
Cohort 2A: Resectable Cohort 2B: Unresectable
Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 status
Cohort 3A: High-risk HER2+ breast cancer (any ER, PR status allowed); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3B: High-risk triple negative breast cancer (TNBC); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3C: HR-positive/HER2-negative invasive breast carcinoma with either \>4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes and at least one of the following: tumor size \>5 cm, histologic grade 3, or validated gene expression assay indicating high recurrence risk (OncotypeDx score \> 26, MammaPrint high, ProSigna high, EndoPredict high)
Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma
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, or paranasal sinus
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 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.
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
Interventions
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Eligibility Criteria
The primary study population will include participants with invasive bladder/upper urinary tract carcinoma, NSCLC, breast cancer, cutaneous melanoma, esophageal carcinoma, gastroesophageal junction carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, squamous cell carcinoma of the head and neck, epithelial ovarian/Fallopian tube carcinoma, endometrial cancer, and renal cell carcinoma (RCC) as per inclusion/exclusion criteria below. Participants with rectal adenocarcinoma undergoing pre-operative systemic chemotherapy/chemoradiotherapy- or immunotherapy-containing regimen are included as an exploratory cohort as per inclusion/exclusion criteria below. Inclusion criteria were selected to enroll participants who are predicted to have \>15-20% risk of recurrence within 3 years in order to sufficiently power the study for recurrence events.
You may qualify if:
- 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
- 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),
- +8 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Guardant Health, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2021
First Posted
September 28, 2021
Study Start
September 7, 2021
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2029
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share