ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
NCT ID: NCT05059444
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2020 participants
OBSERVATIONAL
2021-09-07
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 2: Non-small cell lung cancer (stage IB-III)
Cohort 2A: Resectable Cohort 2B: Unresectable
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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)
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 6: Gastric adenocarcinoma (stage II-III)
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 7: Pancreatic adenocarcinoma
That is has been surgically resected or is eligible for surgical resection
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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.
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 10: High-risk endometrial carcinoma
Defined as FIGO stage II-III.
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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.
Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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
No interventions assigned to this group
Interventions
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Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Guardant Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Guardant Health, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Redwood City
Redwood City, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
University of Colorado
Aurora, Colorado, United States
Memorial Healthcare System
Hollywood, Florida, United States
The Oncology Institute of Hope & Innovation
Lakeland, Florida, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Christus Highland/ Boniol
Shreveport, Louisiana, United States
Central Maine Medical Center
Lewiston, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Mayo Clinic (Rochester)
Rochester, Minnesota, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
UNC- Chapel Hill
Chapel Hill, North Carolina, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Crozer-Keystone Health System
Broomall, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
DHR Health Advance Care Center
Edinburg, Texas, United States
The Center for Cancer and Blood Disorders
Forth Worth, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
CHU Besançon
Besançon, , France
Hôpital Franco-Britannique
Levallois-Perret, , France
Institut Paoli-Calmettes
Marseille, , France
Ambroise Paré-Hartmann
Neuilly, , France
APHP Tenon Hospital - Sorbonne
Paris, , France
Asklepios Klinik Altona
Hamburg, , Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, , Germany
Ludwig Maximilian University Munich
Munich, , Germany
Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST, SrL
Meldola, , Italy
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Hospital Teresa Herrera (C.H.U.A.C)
A Coruña, , Spain
Vall Hebron Institute of Oncology
Barcelona, , Spain
Hospital Clinic of Barcelona
Barcelona, , Spain
ICO Institut Catala d'Oncologia
Barcelona, , Spain
Instituto Catalan de Oncologia de Girona
Girona, , Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
CIOSS HM Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
CCS Hospital Universitari Parc Taulí
Sabadell, , Spain
Hospital Clinico de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Susan Binkley
Role: primary
Sarah Shilling
Role: primary
Susanna Lee
Role: primary
Alexandra Clark
Role: primary
Clinical Trial Operations
Role: primary
Emily Harper
Role: primary
Machelle Seymour
Role: primary
Shanna Kennedy
Role: primary
Alex Lieberman
Role: primary
Nancy Hassan
Role: primary
Jessica Bolduc
Role: primary
Angela Newman
Role: primary
Renee Bradshaw
Role: primary
Percy Yeung
Role: primary
Chris Hilliiard
Role: primary
Maria Clark
Role: primary
Jennifer Martinez
Role: primary
Willdragon Wang
Role: primary
Katelyn Bean
Role: primary
Angela Buffkin
Role: primary
Carson Lee Gallo
Role: primary
Saketh Nadimpalli
Role: primary
Edgar Lopez Pacheco
Role: primary
Anna Rose Abangan
Role: primary
James Denno
Role: primary
Angela Nuttall
Role: primary
Rachel Luedtke
Role: primary
Christine Guglielmetti-Bargot
Role: primary
Hajar Eddahbi
Role: primary
Sameh Bou Ali
Role: primary
Messaouda Merzoug
Role: primary
Hakima Manseur
Role: primary
Dirk Arnold
Role: primary
Josef Huber
Role: primary
C. Benedikt Westphalen
Role: primary
Emanuela Montanari
Role: primary
Erika Gervasi
Role: primary
Ilenia Marino
Role: primary
Sabela Varela Rodriguez
Role: primary
Pol Sisó Camarasa
Role: primary
Debora Moreno Fernandez
Role: primary
Ana Rosa Garcia Oliva
Role: primary
Begona Martin
Role: primary
Sara Suárez Guerra
Role: primary
Raquel Rodriguez
Role: primary
Claudia Morrugares Portero
Role: primary
Begoña Martinez Montesino
Role: primary
Juan Manuel Escandell
Role: primary
Jose Garcia Ruiz
Role: primary
Iria Portos
Role: primary
Matteo Stocco
Role: primary
Other Identifiers
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02-MX-003
Identifier Type: -
Identifier Source: org_study_id
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