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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Trial Status: active
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.
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 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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05059444.
