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Clinical Trials in the USA / NCT05059444
Recruiting

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

NCT05059444 · tracked via the Priya Life Science USA tracker
Sponsor
Guardant Health, Inc.
Phase
Started
2021-09-07
Last updated
2026-09-14

Condition(s) studied

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)

Trial sites (57)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT05059444 on ClinicalTrials.gov ↗ ← All trials in the USA