ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE)

  • End date
    Feb 19, 2028
  • participants needed
  • sponsor
    Guardant Health, Inc.
Updated on 7 October 2022
squamous cell carcinoma
lung cancer
gastric adenocarcinoma
pancreatic adenocarcinoma
primary tumor
cancer chemotherapy
liquid biopsy
fallopian tube
cancer recurrence
endometrioid adenocarcinoma
endometrial carcinoma
clear cell adenocarcinoma
endometrioid carcinoma
lung carcinoma
malignant melanoma of skin


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.

Condition 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
Treatment Guardant Reveal
Clinical Study IdentifierNCT05059444
SponsorGuardant Health, Inc.
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Age > 18 years old AND
Were treated with curative 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 blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer
Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as
Primary Study Cohorts
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
Cohort 2: Non-small cell lung cancer (stage II-III)
Cohort 3: Invasive breast carcinoma with all of the following
Clinical stage T1-4/N0-3/M0 at presentation AND Completed preoperative systemic
chemotherapy-containing regimen AND Underwent definitive surgical resection of the primary
tumor AND Has pathological evidence of residual invasive carcinoma in the breast and/or
axillary lymph nodes AND Hormone receptor and HER2 status are known
Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma
Exploratory Cohorts
treated with curative intent
Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)
Cohort 6: Gastric adenocarcinoma (stage II-III)
Cohort 7: Surgically resected pancreatic adenocarcinoma
Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-III
oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal
sinus, and salivary gland cancers)
Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as stage
IC-III or stage I that has high grade (grade 3-4) or clear cell histology)
Cohort 10: High-risk endometrial carcinoma (defined as having any of the following
serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply
invasive (T1b or greater) endometrioid carcinoma, stage III disease (any 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)

Exclusion Criteria

History of allogeneic organ or tissue transplant
Index cancer has neuroendocrine histology
History of another primary cancer, with the exception of the following (if adequately
treated and the patient is without evidence of disease at the time of enrollment): in
situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason
score < 6) with PSA in the normal range, and stage I papillary thyroid carcinoma
Known distant metastasis at time of enrollment (with the exception of participants
with limited/resectable stage IV cutaneous melanoma or RCC)
Is participating in a clinical trial or another observational study that is evaluating
the performance of another genomic test in the post-treatment surveillance setting at
predicting/detecting recurrence
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