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Bladder CarcinomaORACLENCT05059444

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

An observational study of Bladder Carcinoma and Ureter Carcinoma, run by Guardant Health, Inc. at 57 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Guardant Reveal
How many people
2,285 participants
Where
57 sitesin 5 countries
Study dates
7 Sep 2021to Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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 3 years as outlined in the study protocol and informed consent AND
Show all 23Show fewer
  • Have at least one Landmark blood sample collected. Landmark samples are collected 3-12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant's planned treatment regimen
  • 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: Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus),
  • Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology),
  • Cohort 10: Endometrial carcinoma (2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype),
  • Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent)
  • Cohort 12: Colorectal adenocarcinoma Cohort 12A: 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 OR Cohort 12B: Colon adenocarcinoma (stage II-III)

Who cannot join

  • 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 (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), 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)

Trial locations and contacts

57 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trial Operations contact

8556988887

mrdoraclestudy@guardanthealth.com

57 sites in 5 countries

United States33 sites, 25 recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Sarah Loether

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Emily Harper

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

    Susan Binkley

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Terminated

  • Crozer-Keystone Health System

    Broomall, Pennsylvania, 19008

    Terminated

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

    Charmaine Metrolis

    Recruiting

  • UNC- Chapel Hill

    Chapel Hill, North Carolina, 27599

    Adrianna Warner

    Recruiting

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

    Terminated

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Gabby Redrick

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Molly McGuire

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Percy Yeung

    Recruiting

  • DHR Health Advance Care Center

    Edinburg, Texas, 78539

    Edgar Lopez Pacheco

    Recruiting

  • The Center for Cancer and Blood Disorders

    Forth Worth, Texas, 76104

    Anna Rose Abangan

    Recruiting

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

    Angela Newman

    Recruiting

  • Memorial Healthcare System

    Hollywood, Florida, 33021

    Machelle Seymour

    Recruiting

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

    Terminated

  • University of California, San Diego

    La Jolla, California, 92093

    Susanna Lee

    Recruiting

  • The Oncology Institute of Hope & Innovation

    Lakeland, Florida, 33812

    Chantelle Passmore

    Recruiting

  • Central Maine Medical Center

    Lewiston, Maine, 04240

    Terminated

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Angela Buffkin

    Recruiting

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

    Minqi Haung

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Terminated

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Alexandria Adams

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Willdragon Wang

    Recruiting

  • Redwood City

    Redwood City, California, 94063

    Clinical Trial Operations

    Recruiting

  • Mayo Clinic (Rochester)

    Rochester, Minnesota, 55905

    Renee Bradshaw

    Recruiting

  • Carolina Blood and Cancer Care Associates

    Rock Hill, South Carolina, 29732

    Terminated

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

    Terminated

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

    Angela Nuttall

    Recruiting

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    James Denno

    Recruiting

  • Christus Highland/ Boniol

    Shreveport, Louisiana, 71105

    Cynthia Allgood

    Recruiting

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

    Jennifer Martinez

    Recruiting

  • WellSpan Medical Oncology & Hematology at York Cancer Center

    York, Pennsylvania, 17403

    Clarrisa Vega

    Recruiting

Other trials in United States

Spain13 sites, 13 recruiting

  • Hospital Teresa Herrera (C.H.U.A.C)

    A Coruña, 15006

    Sabela Varela Rodriguez

    Recruiting

  • Vall Hebron Institute of Oncology

    Barcelona, 08035

    Carmen Martinez

    Recruiting

  • Hospital Clinic of Barcelona

    Barcelona, 08036

    Debora Moreno Fernandez

    Recruiting

  • ICO Institut Catala d'Oncologia

    Barcelona, 08908

    Marc Orozco Quer

    Recruiting

  • Instituto Catalan de Oncologia de Girona

    Girona, 17007

    Begona Martin

    Recruiting

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria

    Sara Suárez Guerra

    Recruiting

  • Hospital San Carlos

    Madrid, 28040

    Carla Mesquida Reig

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Adriana Gascó Sánchez

    Recruiting

  • CIOSS HM Sanchinarro

    Madrid, 28050

    Cristina Bressel

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

    Desireeh Fernandez Lopez

    Recruiting

  • CCS Hospital Universitari Parc Taulí

    Sabadell, 08208

    Jose Garcia Ruiz

    Recruiting

  • Hospital Clinico de Santiago de Compostela

    Santiago de Compostela, 15706

    Iria Portos

    Recruiting

  • Hospital Clínico de Valencia

    Valencia, 46010

    Matteo Stocco

    Recruiting

Other trials in Spain

France5 sites, 5 recruiting

  • CHU Besançon

    Besançon, 25000

    Mathilde Doney

    Recruiting

  • Hôpital Franco-Britannique

    Levallois-Perret, 92300

    Hajar Eddahbi

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Ines Ayad

    Recruiting

  • Ambroise Paré-Hartmann

    Neuilly, 92200

    Rayene Soualhi

    Recruiting

  • APHP Tenon Hospital - Sorbonne

    Paris, 75020

    Hakima Manseur

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Petra Frey

    Recruiting

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

    Nunzia Gallo

    Recruiting

  • Ludwig Maximilian University Munich

    Munich, 81377

    Doerte Tesch

    Recruiting

Other trials in Germany

Italy3 sites, 3 recruiting

  • Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST, SrL

    Meldola, 47014

    Michela Spreafico

    Recruiting

  • Azienda USL-IRCCS di Reggio Emilia

    Reggio Emilia, 42123

    Federica Poli

    Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Ilenia Marino

    Recruiting

Other trials in Italy

About this study

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.

Being tested
Guardant Reveal
Medical subject headings
Urinary Bladder Neoplasms, Ureteral Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Esophageal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guardant RevealDiagnostic test

    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.

Study groups in NCT05059444
Study groupRoleWhat they receive
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)Not described
Receives: Diagnostic Test: Guardant Reveal
Cohort 2: Non-small cell lung cancer (stage IB-III)Cohort 2A: Resectable Cohort 2B: Unresectable
Receives: Diagnostic Test: Guardant Reveal
Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 statusCohort 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)
Receives: Diagnostic Test: Guardant Reveal
Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanomaNot described
Receives: Diagnostic Test: Guardant Reveal
Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)Not described
Receives: Diagnostic Test: Guardant Reveal
Cohort 6: Gastric adenocarcinoma (stage II-III)Not described
Receives: Diagnostic Test: Guardant Reveal
Cohort 7: Pancreatic adenocarcinomaThat is has been surgically resected or is eligible for surgical resection
Receives: Diagnostic Test: Guardant Reveal
Cohort 8: Invasive squamous cell carcinoma of the head and neckIncludes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus
Receives: Diagnostic Test: Guardant Reveal
Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinomaDefined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology
Receives: Diagnostic Test: Guardant Reveal
Cohort 10: Endometrial carcinomaDefined as 2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype
Receives: Diagnostic Test: Guardant Reveal
Cohort 11: High-risk renal cell carcinomaDefined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent).
Receives: Diagnostic Test: Guardant Reveal
Cohort 12: Colorectal adenocarcinoma12A 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
Receives: Diagnostic Test: Guardant Reveal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

Secondary outcomes (5)

  1. 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.

    Measured: 3 years

  2. 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).

    Measured: 3 years

  3. Lead Time

    Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.

    Measured: 3 years

  4. Specificity

    Specificity defined as the proportion of participants who are recurrence-free who have ctDNA not detected.

    Measured: 3 years

  5. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2021
  2. Study start7 Sep 2021
  3. Primary completionAug 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,285 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05059444
Sponsor's protocol ID
02-MX-003
Acronym
ORACLE
Status last verified
Sep 2026
First submitted
16 Sep 2021
Last updated
14 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Carcinoma and Ureter Carcinoma, run by Guardant Health, Inc. at 57 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Spain, France, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Operations (8556988887, mrdoraclestudy@guardanthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distant Recurrence Free Interval (D-RFi) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05059444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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