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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy 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 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 Exploratory Cohorts - 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 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), - 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) - 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 2: Non-small cell lung cancer (stage IB-III)
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 status Cohort 3A: High-risk HER2+ breast cancer (any ER, PR status allowed); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3B: High-risk triple negative breast cancer (TNBC); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3C: HR-positive/HER2-negative invasive breast carcinoma with either >4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes and at least one of the following: tumor size >5 cm, histologic grade 3, or validated gene expression assay indicating high recurrence risk (OncotypeDx score > 26, MammaPrint high, ProSigna high, EndoPredict high)
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 6: Gastric adenocarcinoma (stage II-III)
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 7: Pancreatic adenocarcinoma That is has been surgically resected or is eligible for surgical resection
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 8: Invasive squamous cell carcinoma of the head and neck Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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).
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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).
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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.
  • Diagnostic Test: Guardant Reveal
    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35205
Contact:
Susan Binkley

More Details

Status
Recruiting
Sponsor
Guardant Health, Inc.

Study Contact

Clinical Trial Operations
8556988887
mrdoraclestudy@guardanthealth.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.