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 AdenocarcinomaColon Adenocarcinoma
Investigational drug(s) / intervention(s)
Guardant Reveal
Guardant Reveal: Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 3 years as outlined in the study protocol and informed consent AND
* Have at least one Landmark blood sample collected. Landmark samples are collected 3-12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant's planned treatment regimen
* 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: Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB HPV-negative or stage III-IVB HPV-positive 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, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology),
* Cohort 10: Endometrial carcinoma (2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype),
* Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent)
* Cohort 12: Colorectal adenocarcinoma Cohort 12A: 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 OR Cohort 12B: Colon adenocarcinoma (stage II-III)
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 (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), 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)
Primary outcome measure(s)
Distant Recurrence Free Interval (D-RFi) — 3 years 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.
Trial sites (57)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Ironwood Cancer & Research Centers
Chandler
Arizona
Recruiting
Genesis Cancer Center
Hot Springs
Arkansas
Terminated
University of California, San Diego
La Jolla
California
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach
California
Recruiting
Redwood City
Redwood City
California
Recruiting
Sutter Institute for Medical Research
Sacramento
California
Terminated
University of Colorado
Aurora
Colorado
Recruiting
Memorial Healthcare System
Hollywood
Florida
Recruiting
The Oncology Institute of Hope & Innovation
Lakeland
Florida
Recruiting
Tulane Cancer Center
New Orleans
Louisiana
Recruiting
Christus Highland/ Boniol
Shreveport
Louisiana
Recruiting
Central Maine Medical Center
Lewiston
Maine
Terminated
Massachusetts General Hospital
Boston
Massachusetts
Terminated
Cancer & Hematology Centers of Western Michigan
Grand Rapids
Michigan
Recruiting
Mayo Clinic (Rochester)
Rochester
Minnesota
Recruiting
Astera Cancer Care
East Brunswick
New Jersey
Recruiting
Icahn School of Medicine at Mount Sinai
New York
New York
Terminated
UNC- Chapel Hill
Chapel Hill
North Carolina
Recruiting
The Christ Hospital Cancer Center
Cincinnati
Ohio
Terminated
Cleveland Clinic
Cleveland
Ohio
Recruiting
Toledo Clinic Cancer Center
Toledo
Ohio
Recruiting
Crozer-Keystone Health System
Broomall
Pennsylvania
Terminated
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
WellSpan Medical Oncology & Hematology at York Cancer Center
York
Pennsylvania
Recruiting
Carolina Urologic Research Center
Myrtle Beach
South Carolina
Recruiting
Carolina Blood and Cancer Care Associates
Rock Hill
South Carolina
Terminated
UT Southwestern Medical Center
Dallas
Texas
Recruiting
DHR Health Advance Care Center
Edinburg
Texas
Recruiting
The Center for Cancer and Blood Disorders
Forth Worth
Texas
Recruiting
The University of Texas Health Science Center at San Antonio
San Antonio
Texas
Recruiting
Utah Cancer Specialists
Salt Lake City
Utah
Recruiting
ThedaCare Regional Cancer Center
Appleton
Wisconsin
Recruiting
CHU Besançon
Besançon
France
Recruiting
Hôpital Franco-Britannique
Levallois-Perret
France
Recruiting
Institut Paoli-Calmettes
Marseille
France
Recruiting
Ambroise Paré-Hartmann
Neuilly
France
Recruiting
APHP Tenon Hospital - Sorbonne
Paris
France
Recruiting
Asklepios Klinik Altona
Hamburg
Germany
Recruiting
SLK-Kliniken Heilbronn GmbH
Heilbronn
Germany
Recruiting
+ 17 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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