An observational study in Bladder Carcinoma, Ureter Carcinoma and Renal Pelvis Carcinoma, sponsored by Guardant Health, Inc.. Recruiting at 57 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Guardant Health, Inc. · Observational
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 2,285 is above the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Guardant Health, Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The primary study population will include participants with invasive bladder/upper urinary tract carcinoma, NSCLC, breast cancer, cutaneous melanoma, esophageal carcinoma, gastroesophageal junction carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, squamous cell carcinoma of the head and neck, epithelial ovarian/Fallopian tube carcinoma, endometrial cancer, renal cell carcinoma (RCC), and colorectal cancer as per inclusion/exclusion criteria below. Inclusion criteria were selected to enroll participants who are predicted to have >15-20% risk of recurrence within 3 years in order to sufficiently power the study for recurrence events.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Primary Study Cohorts
Cohort 2A: Resectable OR Cohort 2B: Unresectable,
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,
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Guardant Reveal
Cohort 2A: Resectable Cohort 2B: Unresectable
Diagnostic Test: Guardant Reveal
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
Diagnostic Test: Guardant Reveal
Diagnostic Test: Guardant Reveal
Diagnostic Test: Guardant Reveal
That is has been surgically resected or is eligible for surgical resection
Diagnostic Test: Guardant Reveal
Includes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus
Diagnostic Test: Guardant Reveal
Defined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology
Diagnostic Test: Guardant Reveal
Defined as 2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype
Diagnostic Test: Guardant Reveal
Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent).
Diagnostic Test: Guardant Reveal
12A Rectal Adenocarcinoma: 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 12B Colon 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.
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.
Time frame: 3 years
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.
Time frame: 3 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).
Time frame: 3 years
Lead Time
Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.
Time frame: 3 years
Specificity
Specificity defined as the proportion of participants who are recurrence-free who have ctDNA not detected.
Time frame: 3 years
Negative Predictive Value
Negative predictive value (NPV) defined as the proportion of participants who have ctDNA not detected at the Landmark or any surveillance timepoint who do not recur.
Time frame: 3 years
Recurrence-free interval (RFi)
Recurrence-free interval (RFi) defined as the time from the end of primary treatment until the appearance/occurrence of any recurrence (distant, regional, and/or local) of the Index Cancer. Subjects without recurrence will be censored at the time of last follow-up of their Index Cancer.
Time frame: 3 years
Association with resolution of indeterminate findings
1. The proportion of individuals whose indeterminate finding is ultimately confirmed to be disease recurrence who have ctDNA detected at the initial time the indeterminate finding is identified and 2. The proportion of ctDNA not detected participants whose indeterminate findings is ultimately confirmed to be benign.
Time frame: 3 years
Sensitivity for local recurrence
Sensitivity for local recurrence defined as the proportion of participants who have localized recurrence (e.g., in the absence of distant metastasis) who have ctDNA detected at or before the time of clinical detection of a localized recurrence; using landmark and serial timepoints.
Time frame: 3 years
Index Cancer-Specific Survival (ICSS)
Index Cancer-Specific Survival (ICSS) defined as the time from the date of diagnosis until the date of death from the subject's Index Cancer. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Time frame: 3 years
Overall Survival (OS)
Overall Survival (OS) defined as the time from the date of diagnosis until the date of death from any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Time frame: 3 years
Rate of ctDNA clearance with therapy
Rate of ctDNA clearance with therapy defined as the proportion of patients who have ctDNA detected at a timepoint before starting a new therapy whose ctDNA becomes undetectable at a subsequent timepoint.
Time frame: 3 years
Association of ctDNA detection status with pathologic response
Association of ctDNA detection status with pathologic response defined as the rate of ctDNA detection in individuals with residual invasive cancer in the resected specimen (as well as be residual cancer burden scores, where applicable), and in those with a complete pathologic response (defined as no invasive cancer detectable in the resection specimens) following neoadjuvant systemic therapy.
Time frame: 3 years
Association of genomic/epigenomic profiles with patient outcomes
Association of genomic/epigenomic profiles with patient outcomes defined as the association between integrated genomic profiles (e.g., somatic mutations, copy number changes, tumor mutation burden etc) and epigenomic profiles (e.g., promoter methylation etc) with patient outcomes will be explored to determine if specific signatures define molecular subtypes with distinct recurrence rate/patterns, response to treatment, and/or longitudinal evolution of the tumor.
Time frame: 3 years
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Guardant Health, Inc.