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RecruitingObservational

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

NCT ID: NCT05059444Sponsor: Guardant Health, Inc.Last updated: 2025-08-22

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.

Arms & interventions

  • Diagnostic TestGuardant Reveal

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

Outcome measures

Primary

  • Distant Recurrence Free Interval (D-RFi)

    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.

    Time frame: 3 years

Secondary

  • Sensitivity

    Time frame: 3 years

  • Positive Predictive Value

    Time frame: 3 years

  • Lead Time

    Time frame: 3 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 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 locations (33)

University of Alabama at Birmingham

Birmingham, Alabama, 35205

Recruiting
Susan Binkley · Contact

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224

Recruiting
Sarah Shilling · Contact

Genesis Cancer Center

Hot Springs, Arkansas, 71913

Terminated

University of California, San Diego

La Jolla, California, 92093

Recruiting
Susanna Lee · Contact

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Recruiting
Alexandra Clark · Contact

Redwood City

Redwood City, California, 94063

Recruiting
Clinical Trial Operations · Contact

Sutter Institute for Medical Research

Sacramento, California, 95816

Terminated

University of Colorado

Aurora, Colorado, 80045

Recruiting
Emily Harper · Contact

Memorial Healthcare System

Hollywood, Florida, 33021

Recruiting
Machelle Seymour · Contact

The Oncology Institute of Hope & Innovation

Lakeland, Florida, 33812

Recruiting
Shanna Kennedy · Contact

Tulane Cancer Center

New Orleans, Louisiana, 70112

Recruiting
Alex Lieberman · Contact

Christus Highland/ Boniol

Shreveport, Louisiana, 71105

Recruiting
Nancy Hassan · Contact

Central Maine Medical Center

Lewiston, Maine, 04240

Recruiting
Jessica Bolduc · Contact

Massachusetts General Hospital

Boston, Massachusetts, 02114

Terminated

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503

Recruiting
Angela Newman · Contact

Mayo Clinic (Rochester)

Rochester, Minnesota, 55905

Recruiting
Renee Bradshaw · Contact

Astera Cancer Care

East Brunswick, New Jersey, 08816

Recruiting
Percy Yeung · Contact

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Terminated

UNC- Chapel Hill

Chapel Hill, North Carolina, 27599

Recruiting
Chris Hilliiard · Contact

The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219

Terminated

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Maria Clark · Contact

Toledo Clinic Cancer Center

Toledo, Ohio, 43623

Recruiting
Jennifer Martinez · Contact

Crozer-Keystone Health System

Broomall, Pennsylvania, 19008

Terminated

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Willdragon Wang · Contact

Cancer Care Associates of York

York, Pennsylvania, 17403

Recruiting
Katelyn Bean · Contact

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

Recruiting
Angela Buffkin · Contact

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732

Recruiting
Carson Lee Gallo · Contact

UT Southwestern Medical Center

Dallas, Texas, 75390

Recruiting
Saketh Nadimpalli · Contact

DHR Health Advance Care Center

Edinburg, Texas, 78539

Recruiting
Edgar Lopez Pacheco · Contact

The Center for Cancer and Blood Disorders

Forth Worth, Texas, 76104

Recruiting
Anna Rose Abangan · Contact

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Recruiting
James Denno · Contact

Utah Cancer Specialists

Salt Lake City, Utah, 84106

Recruiting
Angela Nuttall · Contact

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

Recruiting
Rachel Luedtke · Contact