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Blood test aims to catch Cancer's return earlier

NCT ID NCT05059444

Diagnosis Sponsor: Guardant Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

The ORACLE study watches people who have finished treatment for early-stage solid tumors, such as lung, breast, colon, and pancreatic cancers. Researchers want to see if a blood test called Guardant Reveal can find tiny traces of tumor DNA that might signal the cancer is coming back. Participants give blood samples regularly during their standard follow-up care. By comparing test results with what happens to participants over time, the study aims to learn how well the test detects recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Guardant Reveal, a blood test that looks for tiny amounts of tumor DNA
What this could lead to
If the blood test works, doctors could one day use a simple blood draw to catch cancer recurrence earlier than scans or symptoms, possibly leading to faster treatment.
What could go wrong
The test may miss some recurrences or give false alarms, leading to unnecessary worry and tests. This study observes people over time; it does not test whether acting on the test results improves outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,285 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 3 years as outlined in the study protocol and informed consent AND * 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) 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 (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)

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Conditions

The condition(s) this trial relates to.

carcinoma of esophagus Carcinoma, Ovarian Epithelial colon adenocarcinoma colonic neoplasm cutaneous melanoma endometrial carcinoma endometrium neoplasm Esophageal Neoplasms fallopian tube carcinoma fallopian tube neoplasm gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma invasive breast carcinoma melanoma non-small cell lung carcinoma ovarian carcinoma pancreatic adenocarcinoma rectal neoplasm rectum adenocarcinoma renal cell carcinoma renal pelvis carcinoma Squamous Cell Carcinoma of Head and Neck ureter cancer ureter carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder carcinoma Colon adenocarcinoma Cutaneous melanoma Endometrial carcinoma Epithelial ovarian carcinoma Esophageal carcinoma Fallopian tube carcinoma Gastric adenocarcinoma Gastroesophageal junction carcinoma Invasive breast carcinoma Non-small cell lung cancer Pancreatic adenocarcinoma Rectal adenocarcinoma Renal cell carcinoma Renal pelvis carcinoma Squamous cell carcinoma of the head and neck Ureter carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    49 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • APHP Tenon Hospital - Sorbonne

    RECRUITING

    Paris, 75020, France

  • Ambroise Paré-Hartmann

    RECRUITING

    Neuilly, 92200, France

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Azienda USL-IRCCS di Reggio Emilia

    RECRUITING

    Reggio Emilia, 42123, Italy

  • CCS Hospital Universitari Parc Taulí

    RECRUITING

    Sabadell, 08208, Spain

  • CHU Besançon

    RECRUITING

    Besançon, 25000, France

  • CIOSS HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Cancer & Hematology Centers of Western Michigan

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Carolina Blood and Cancer Care Associates

    TERMINATED

    Rock Hill, South Carolina, 29732, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Central Maine Medical Center

    TERMINATED

    Lewiston, Maine, 04240, United States

  • Christus Highland/ Boniol

    RECRUITING

    Shreveport, Louisiana, 71105, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Crozer-Keystone Health System

    TERMINATED

    Broomall, Pennsylvania, 19008, United States

  • DHR Health Advance Care Center

    RECRUITING

    Edinburg, Texas, 78539, United States

  • Genesis Cancer Center

    TERMINATED

    Hot Springs, Arkansas, 71913, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hospital Clinic of Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico de Santiago de Compostela

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hospital Clínico de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital San Carlos

    RECRUITING

    Madrid, 28040, Spain

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

    RECRUITING

    A Coruña, 15006, Spain

  • Hospital Universitario Insular de Gran Canaria

    RECRUITING

    Las Palmas de Gran Canaria, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hôpital Franco-Britannique

    RECRUITING

    Levallois-Perret, 92300, France

  • ICO Institut Catala d'Oncologia

    RECRUITING

    Barcelona, 08908, Spain

  • Icahn School of Medicine at Mount Sinai

    TERMINATED

    New York, New York, 10029, United States

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13009, France

  • Instituto Catalan de Oncologia de Girona

    RECRUITING

    Girona, 17007, Spain

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

    RECRUITING

    Meldola, 47014, Italy

  • Ironwood Cancer & Research Centers

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Ludwig Maximilian University Munich

    RECRUITING

    Munich, 81377, Germany

  • Massachusetts General Hospital

    TERMINATED

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic (Rochester)

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Healthcare System

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Redwood City

    RECRUITING

    Redwood City, California, 94063, United States

  • SLK-Kliniken Heilbronn GmbH

    RECRUITING

    Heilbronn, 74078, Germany

  • Sutter Institute for Medical Research

    TERMINATED

    Sacramento, California, 95816, United States

  • The Center for Cancer and Blood Disorders

    RECRUITING

    Forth Worth, Texas, 76104, United States

  • The Christ Hospital Cancer Center

    TERMINATED

    Cincinnati, Ohio, 45219, United States

  • The Oncology Institute of Hope & Innovation

    RECRUITING

    Lakeland, Florida, 33812, United States

  • The University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • ThedaCare Regional Cancer Center

    RECRUITING

    Appleton, Wisconsin, 54911, United States

  • Toledo Clinic Cancer Center

    RECRUITING

    Toledo, Ohio, 43623, United States

  • Tulane Cancer Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • UNC- Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of California, San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Utah Cancer Specialists

    RECRUITING

    Salt Lake City, Utah, 84106, United States

  • Vall Hebron Institute of Oncology

    RECRUITING

    Barcelona, 08035, Spain

  • WellSpan Medical Oncology & Hematology at York Cancer Center

    RECRUITING

    York, Pennsylvania, 17403, United States

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