Recruiting

Liquid Biopsy

Sponsor:

Guardant Health, Inc.

Code:

NCT05059444

Conditions

Bladder Carcinoma

Ureter Carcinoma

Renal Pelvis Carcinoma

Non-small Cell Lung Cancer

Invasive Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Guardant Reveal

Study Details

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.

Conditions

Bladder Carcinoma

Ureter Carcinoma

Renal Pelvis Carcinoma

Non-small Cell Lung Cancer

Invasive Breast Carcinoma

Study ID

NCT05059444

Start date

Sep 7, 2021

Status verified date

Aug, 2025

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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:

  • 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)

Study Design

Enrollment

2020 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.

Primary outcome measure

  • Distant Recurrence Free Interval (D-RFi) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trial Operations

8556988887mrdoraclestudy@guardanthealth.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Ironwood Cancer & Research Centers

Recruiting

Chandler, Arizona, United States, 85224

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Redwood City

Recruiting

Redwood City, California, United States, 94063

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

The Oncology Institute of Hope & Innovation

Recruiting

Lakeland, Florida, United States, 33812

Tulane Cancer Center

Recruiting

New Orleans, Louisiana, United States, 70112

Christus Highland/ Boniol

Recruiting

Shreveport, Louisiana, United States, 71105

Central Maine Medical Center

Recruiting

Lewiston, Maine, United States, 04240

Cancer & Hematology Centers of Western Michigan

Recruiting

Grand Rapids, Michigan, United States, 49503

Mayo Clinic (Rochester)

Recruiting

Rochester, Minnesota, United States, 55905

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

UNC- Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Toledo Clinic Cancer Center

Recruiting

Toledo, Ohio, United States, 43623

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Carolina Blood and Cancer Care Associates

Recruiting

Rock Hill, South Carolina, United States, 29732

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

DHR Health Advance Care Center

Recruiting

Edinburg, Texas, United States, 78539

The Center for Cancer and Blood Disorders

Recruiting

Forth Worth, Texas, United States, 76104

The University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84106

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

More Information

Sponsor

Guardant Health, Inc.

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Guardant Health, Inc. on 2025-08-22.