ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Recruiting now

Conditions studied: Bladder Carcinoma, Ureter Carcinoma, Renal Pelvis Carcinoma, Non-small Cell Lung Cancer, Invasive Breast Carcinoma, Cutaneous Melanoma, Esophageal Carcinoma, Gastroesophageal Junction Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck, Epithelial Ovarian Carcinoma, Fallopian Tube Carcinoma, Endometrial Carcinoma, Renal Cell Carcinoma, Rectal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT05059444

Run by

Guardant Health, Inc.

People needed

2020

Starts

2021-09-07

Expected to finish

2029-08-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• The Center for Cancer and Blood Disorders — Forth Worth, Texas, United States (enrolling)
• Ironwood Cancer & Research Centers — Chandler, Arizona, United States (enrolling)
• Carolina Blood and Cancer Care Associates — Rock Hill, South Carolina, United States (enrolling)
• Redwood City — Redwood City, California, United States (enrolling)
• DHR Health Advance Care Center — Edinburg, Texas, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• University of California, San Diego — La Jolla, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
• Christus Highland/ Boniol — Shreveport, Louisiana, United States (enrolling)
• Central Maine Medical Center — Lewiston, Maine, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Cancer & Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States (enrolling)
• Mayo Clinic (Rochester) — Rochester, Minnesota, United States (enrolling)
• Astera Cancer Care — East Brunswick, New Jersey, United States (enrolling)
• Memorial Healthcare System — Hollywood, Florida, United States (enrolling)
• UNC- Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• The Oncology Institute of Hope & Innovation — Lakeland, Florida, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Toledo Clinic Cancer Center — Toledo, Ohio, United States (enrolling)
• Tulane Cancer Center — New Orleans, Louisiana, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Cancer Care Associates of York — York, Pennsylvania, United States (enrolling)
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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