ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
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.
Checked against the public recordLast updated Aug 22, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Guardant Health, Inc.
- Interventions being studied
- Diagnostic Test: Guardant Reveal
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
- Ironwood Cancer & Research CentersChandler, Arizona
- Genesis Cancer CenterHot Springs, Arkansas
- University of California, San DiegoLa Jolla, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Redwood CityRedwood City, California
- Sutter Institute for Medical ResearchSacramento, California
- University of ColoradoAurora, Colorado
- Memorial Healthcare SystemHollywood, Florida
- The Oncology Institute of Hope & InnovationLakeland, Florida
- Tulane Cancer CenterNew Orleans, Louisiana
- Christus Highland/ BoniolShreveport, Louisiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 22, 2025. Always confirm current availability with the study team.