ORACLE: Observation Of ResiduAl Cancer With Liquid Biopsy Evaluation

Study Overview

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.

N/A

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

DIAGNOSTIC_TEST: Guardant Reveal

02-MX-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-09-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-04
First Submitted that Met QC Criteria 2021-09-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-09
First Posted (ACTUAL) 2021-09-28	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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-ris
: Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma
: 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, or paranasal sinus
: 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).	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

Primary Outcome Measures	Measure Description	Time Frame
Distant Recurrence Free Interval (D-RFi)	The primary endpoint, distant recurrence-free interval (D-RFi), will be evaluated for each of the primary study cohorts. D-RFi is defined as the time from the end of primary treatment until the time of diagnosis of a distant recurrence of the Index Cancer. Subjects without a distant recurrence will be censored at the time of last follow-up of their Index Cancer.	6 years

Secondary Outcome Measures	Measure Description	Time Frame
Sensitivity	Sensitivity defined as the proportion of participants who develop distant recurrence who have ctDNA detected at or before the time of clinical detection of recurrence.	6 years
Positive Predictive Value	Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected at the landmark or any surveillance timepoint who recur (either distally or locally).	6 years
Lead Time	Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.	6 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trial Operations

Phone Number: 8556988887

Email: mrdoraclestudy@guardanthealth.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Study Director, Guardant Health, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record