Actively Recruiting
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Led by Guardant Health, Inc. · Updated on 2025-08-22
2020
Participants Needed
57
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the ability of a new blood test called Guardant Reveal, developed by Guardant Health, to detect cancer recurrence in people treated for early-stage solid tumors. This observational study aims to link the blood test results with clinical outcomes to show its potential value in monitoring cancer recurrence while considering healthcare costs. The study includes multiple types of cancers such as bladder, lung, breast, melanoma, esophageal, gastric, pancreatic, head and neck, ovarian, endometrial, renal, and rectal cancers. Participants are grouped into different cohorts based on their specific cancer type and stage, including muscle invasive carcinoma, non-small cell lung cancer, various types of breast cancer, melanoma, esophageal, gastric, pancreatic adenocarcinoma, head and neck squamous cell carcinoma, ovarian or fallopian tube carcinoma, endometrial carcinoma, renal cell carcinoma, and rectal adenocarcinoma. The study involves regular blood sample collection using the Guardant Reveal assay at enrollment and during routine medical visits, with follow-up lasting up to 5 years for ongoing monitoring of minimal residual disease and recurrence detection. During the study, participants will provide blood samples at scheduled visits aligned with their regular cancer care follow-up. Researchers will assess outcomes including the time without distant cancer recurrence over 3 years, along with test sensitivity, positive predictive value, and lead time for recurrence detection. Clinical data will be collected and shared anonymously with investigators, and participants will be monitored according to standard care practices throughout the study duration, which may extend up to 5 years or until the study ends in 2029.
CONDITIONS
Brief Title
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years old
- Initial cancer treatment given with curative or radical intent
- Planning to undergo regular follow-up and monitoring for cancer recurrence per standard care
- Provided written informed consent to participate
- Willing to share de-identified clinical data with investigators regularly
- Willing to provide blood samples at enrollment and at clinical visits for up to 5 years
- Have at least one Landmark blood sample
- Have a histologically confirmed qualifying cancer from specified cohorts including muscle invasive bladder, ureter, renal pelvis carcinoma, non-small cell lung cancer, invasive breast carcinoma with known hormone receptor and HER2 status, cutaneous melanoma, esophageal or gastroesophageal junction carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, invasive squamous cell carcinoma of the head and neck, high-risk epithelial ovarian or fallopian tube carcinoma, high-risk endometrial carcinoma, high-risk renal cell carcinoma, or rectal adenocarcinoma
You will not qualify if you...
- History of allogeneic organ or tissue transplant
- Index cancer has predominantly neuroendocrine histology
- History of another primary cancer diagnosed within 3 years, except for certain in situ cancers, non-melanoma skin cancers, low/intermediate risk prostate cancers, stage I papillary thyroid carcinoma, or bilateral/multifocal tumors in the same organ
- Known distant metastasis at enrollment, except for limited/resectable stage IV cutaneous melanoma or renal cell carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for enrollment and baseline blood sample collection
Duration - Up to 5 years
Participants are monitored for cancer recurrence with regular blood sample collections and clinical visits over time.
Blood samples collected at enrollment and during clinical visits for up to 5 years
Trial Site Locations
Total: 57 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
Actively Recruiting
3
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
Terminated
4
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
5
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
6
Redwood City
Redwood City, California, United States, 94063
Actively Recruiting
7
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Terminated
8
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Actively Recruiting
10
The Oncology Institute of Hope & Innovation
Lakeland, Florida, United States, 33812
Actively Recruiting
11
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
12
Christus Highland/ Boniol
Shreveport, Louisiana, United States, 71105
Actively Recruiting
13
Central Maine Medical Center
Lewiston, Maine, United States, 04240
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Terminated
15
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
16
Mayo Clinic (Rochester)
Rochester, Minnesota, United States, 55905
Actively Recruiting
17
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
18
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Terminated
19
UNC- Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
20
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
Terminated
21
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623
Actively Recruiting
23
Crozer-Keystone Health System
Broomall, Pennsylvania, United States, 19008
Terminated
24
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Cancer Care Associates of York
York, Pennsylvania, United States, 17403
Actively Recruiting
26
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
27
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
28
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
29
DHR Health Advance Care Center
Edinburg, Texas, United States, 78539
Actively Recruiting
30
The Center for Cancer and Blood Disorders
Forth Worth, Texas, United States, 76104
Actively Recruiting
31
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
32
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Actively Recruiting
33
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States, 54911
Actively Recruiting
34
CHU Besançon
Besançon, France, 25000
Actively Recruiting
35
Hôpital Franco-Britannique
Levallois-Perret, France, 92300
Actively Recruiting
36
Institut Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
37
Ambroise Paré-Hartmann
Neuilly, France, 92200
Actively Recruiting
38
APHP Tenon Hospital - Sorbonne
Paris, France, 75020
Actively Recruiting
39
Asklepios Klinik Altona
Hamburg, Germany, 22763
Actively Recruiting
40
SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany, 74078
Actively Recruiting
41
Ludwig Maximilian University Munich
Munich, Germany, 81377
Actively Recruiting
42
Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST, SrL
Meldola, Italy, 47014
Actively Recruiting
43
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42123
Actively Recruiting
44
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Actively Recruiting
45
Hospital Teresa Herrera (C.H.U.A.C)
A Coruña, Spain, 15006
Actively Recruiting
46
Vall Hebron Institute of Oncology
Barcelona, Spain, 08035
Actively Recruiting
47
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Actively Recruiting
48
ICO Institut Catala d'Oncologia
Barcelona, Spain, 08908
Actively Recruiting
49
Instituto Catalan de Oncologia de Girona
Girona, Spain, 17007
Actively Recruiting
50
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Actively Recruiting
51
Hospital San Carlos
Madrid, Spain, 28040
Actively Recruiting
52
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
53
CIOSS HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
54
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
55
CCS Hospital Universitari Parc Taulí
Sabadell, Spain, 08208
Actively Recruiting
56
Hospital Clinico de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Actively Recruiting
57
Hospital Clínico de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
C
Clinical Trial Operations
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
12
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