Blood test aims to catch lung cancer before it spreads

NCT ID NCT05117840

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

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study is testing a new blood test (GuardantLUNAR-2) to see how well it can detect lung cancer in people at high risk. About 12,000 smokers aged 50-80 will give a blood sample before their regular low-dose CT scan. The goal is to find out if the blood test is accurate enough to spot cancer early, which could lead to faster treatment and better outcomes.

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Study facts

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

Participants

About 12,000 people

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

Started

Jan 2022

Expected to finish

Dec 2026

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 SHIELD study will recruit patients in separate cancer-risk cohorts with specified pathways for cancer screening. Patients eligible for high frequency cancer screening will be screened for study eligibility per each cohort's criteria.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Subjects aged 50-80 years at time of consent * Increased risk of lung cancer defined by: at least 20 pack-year smoking history and currently smoke or have quit within the past 15 years * Undergoing or intended to undergo low dose CT scan of the chest for lung cancer screening * Willing to consent to the investigational blood draw during index LDCT screening visit and before any invasive procedures or treatment for lung cancer diagnosis * Willing to consent to a 1-year and additional follow-up per protocol Exclusion Criteria: 1. Subject has quit smoking for 15 or more years 2. Subject has less than 20 pack-year smoking history 3. Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery 4. Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer 5. Preexisting or history of lung cancer 6. Previously diagnosed high-risk lung lesion 7. History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study) 8. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs 9. Currently receiving treatment for pneumonia 10. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent 11. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study 12. Participation in a clinical research study in which an experimental medication and/or medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm

As listed by the trial registrant

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

Lung cancer

Contacts and locations

Locations

3Sync Research

Hialeah, Florida, 33016, United States
3Sync Research

Lake Worth, Florida, 33460, United States
ARC Clinical Research at William Cannon

Austin, Texas, 78745, United States
Adtremed INC

Lutz, Florida, 33548, United States
Adtremed Research Clinic

Tampa, Florida, 33607, United States
Adult Medicine of Lake County

Mt. Dora, Florida, 32757, United States
Advanced Investigative Medicine

Hawthorne, California, 90250, United States
Advocare Pulmonary And Sleep Specialists

Exton, Pennsylvania, 19341, United States
Advocare Pulmonary And Sleep Specialists

Lansdale, Pennsylvania, 19446, United States
Advocare Pulmonary And Sleep Specialists

West Chester, Pennsylvania, 19380, United States
Allure Heath at Mt. Olympus Medical Research

Friendswood, Texas, 77546, United States
Austin Regional Clinic

Austin, Texas, 78726, United States
Berks Schuylkill Respiratory Specialists, Ltd.

Wyomissing, Pennsylvania, 19610, United States
Best Cancer Care & Hematology - Biopharma Informatic

Houston, Texas, 77089, United States
Branson Pulmonology and Sleep Medicine

Branson, Missouri, 65616, United States
CAMC Clinical Trials Center

Charleston, West Virginia, 25304, United States
CHU Amiens Picardie - Centre de Recherche Clinique

Amiens, 80054, France
CTMD Research

Coconut Creek, Florida, 33063, United States
CTMD Research

Palm Springs, Florida, 33406, United States
CTMD Research, Asheville

Asheville, North Carolina, 28804, United States
California Medical Research Associates Inc.

Northridge, California, 91324, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Central Florida Pulmonary Group, P.A.

Altamonte Springs, Florida, 32701, United States
Central Florida Pulmonary Group, P.A.

Orlando, Florida, 32803, United States
Central Florida Pulmonary Group, P.A.

Orlando, Florida, 32825, United States
Centre Hospitalier Alpes Leman

Contamine-sur-Arve, 74130, France
Centre Hospitalier d'Abbeville

Abbeville, 80142, France
Charisma Medical and Research Center

Miami Lakes, Florida, 33014, United States
Christie Clinic

Champaign, Illinois, 61822, United States
Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States
Clinique Teissier

Valenciennes, 59300, France
Coastal Pulmonary and Critical Care, P.L.C.

St. Petersburg, Florida, 33704, United States
Consulta Respira

Mataró, CT, 08302, Spain
Covenant Health System/Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States
DC Research Works

Marietta, Georgia, 30060, United States
Durham VA Medical Center

Durham, North Carolina, 27705, United States
Eagle Clinical Research

Chicago, Illinois, 60621, United States
El Paso Pulmonary Associates

El Paso, Texas, 79902, United States
Family Medical Clinic of North Mississippi

Southaven, Mississippi, 38672, United States
Family Medicine Physicians

Hammond, Louisiana, 70403, United States
Florida Research Center, Inc.

Miami, Florida, 33174, United States
George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States
Great Lakes Medical Research

Westfield, New York, 14787, United States
Great Plains Health

North Platte, Nebraska, 69101, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
HealthPartners Institute

Minneapolis, Minnesota, 55440, United States
Highlands Oncology Group PA

Fayetteville, Arkansas, 72703, United States
Hopital Bicetre

Le Kremlin-Bicêtre, 94270, France
Hopital Europeen

Marseille, 13003, France
Hopital Pasteur CHU de Nice de Pneumologie

Nice, 06001, France
Horizon Clinical Research Group

Cypress, Texas, 77429, United States
Hospital HM Montepríncipe

Boadilla del Monte, MD, 28660, Spain
Hospital HM Puerta del Sur

Móstoles, MD, 28938, Spain
Hospital HM Sanchinarro

Madrid, MD, 28050, Spain
Hospital Recoletas Campo Grande

Valladolid, CL, 47007, Spain
Hospital Vithas Xanit Internacional

Benalmádena, AN, 29630, Spain
Huntsville Research Institute, LLC

Huntsville, Texas, 77340, United States
Hutchinson Clinic - North Waldron

Hutchinson, Kansas, 67502, United States
Hôpitaux du Léman

Thonon-les-Bains, 74200, France
Hõpital Lyon Sud

Pierre-Bénite, 69495, France
Infirmerie Protestante de Lyon

Caluire-et-Cuire, 69300, France
JFK University Medical Center

Edison, New Jersey, 08820, United States
John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States
Las Mias Research and Medical Center

Miami, Florida, 33144, United States
Life Arc Research Centers

Coral Gables, Florida, 33134, United States
Lillestol Research, LLC

Fargo, North Dakota, 58104, United States
Long Island Pulmonary and Sleep Medicine Associates

Hempstead, New York, 11550, United States
Long Island Pulmonary and Sleep Medicine Associates

Rockville Centre, New York, 11570, United States
MacGregor Family Physicians, P.A.

Cary, North Carolina, 27518, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Mayo Clinic Health System Eau Claire

Eau Claire, Wisconsin, 54703, United States
Mayo Clinic La Crosse

La Crosse, Wisconsin, 54601, United States
MedCorps Asthma and Pulmonary Specialists

Maysville, Kentucky, 41056, United States
MedCorps Asthma and Pulmonary Specialists

Cape May Court House, New Jersey, 08210, United States
MedCorps Asthma and Pulmonary Specialists

Linwood, New Jersey, 08221, United States
MedCorps Asthma and Pulmonary Specialists

Sewell, New Jersey, 08080, United States
Memorial Hospital at Gulfport

Gulfport, Mississippi, 39501, United States
Miami Pulmonary Specialists

Miami, Florida, 33173, United States
Mid-South Pulmonary & Sleep Specialists PC

Memphis, Tennessee, 38157, United States
MidSouth Independent Group

Memphis, Tennessee, 38119, United States
Midsouth Independent Group

Memphis, Tennessee, 38104, United States
Midsouth Independent Group

Memphis, Tennessee, 38106, United States
Midsouth Independent Group

Memphis, Tennessee, 38114, United States
Midtown OB/GYN North

Columbus, Georgia, 31901, United States
Monzon Clinical Trials

Miami, Florida, 33144, United States
Multi-Specialty Research Associates, Inc.

Lake City, Florida, 32055, United States
National Research Institute

Hialeah, Florida, 33013, United States
North Jersey Pulmonary Associates

Ridgewood, New Jersey, 07450, United States
Oak Cliff Research

Richardson, Texas, 75081, United States
Ocean Pulmonary Associates

Brick, New Jersey, 08724, United States
Ocean Pulmonary Associates

Toms River, New Jersey, 08755, United States
Ocean University Medical Center

Brick, New Jersey, 08724, United States
Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States
PRX Research

Mesquite, Texas, 75149, United States
Pacific Cancer Medical Center

Anaheim, California, 92801, United States
Peabody Internal Medicine Inc.

Millington, Tennessee, 38053, United States
Peters Medical Research

High Point, North Carolina, 27262, United States
Piedmont Healthcare

Statesville, North Carolina, 28625, United States
Premier Family Physicians

Austin, Texas, 78735, United States
Providence Medical Foundation

Santa Rosa, California, 95403, United States
Providence St. Joseph Hospital Eureka Cancer Program

Eureka, California, 95501, United States
Pulmonary & Sleep Disorders of New Jersey

East Brunswick, New Jersey, 08816, United States
Pulmonary & Sleep Disorders of New Jersey

Monroe, New Jersey, 08831, United States
Pulmonary Critical Care & Sleep Associates, P.A.

Conroe, Texas, 77304, United States
Pulmonary Internists

Edison, New Jersey, 08820, United States
Pulmonary Physicians of South Florida, LLC

Coral Springs, Florida, 33065, United States
Pulmonary Specialists of North Jersey

Englewood, New Jersey, 07631, United States
Pulmonary Specialists of North Jersey

North Bergen, New Jersey, 07047, United States
Pulmonary and Sleep Specialists of Northeast Georgia, PC

Dacula, Georgia, 30019, United States
Pulmonary and Sleep Specialists of Northeast Georgia, PC

Winder, Georgia, 30680, United States
Pulmonary, Critical Care & Sleep Disorders Institute of South Florida

Atlantis, Florida, 33462, United States
Pulmonology Associates Inc.

Broomall, Pennsylvania, 19008, United States
Pulmonology Associates Inc.

Paoli, Pennsylvania, 19301, United States
Pulmonology Associates Inc.

Wynnewood, Pennsylvania, 19096, United States
Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108)

Wynnewood, Pennsylvania, 19096, United States
Randomize Now, LLC

Peachtree City, Georgia, 30269, United States
RespaCare

Bridgewater, New Jersey, 08807, United States
Respiratory and Sleep Specialists, LLC

Princeton, New Jersey, 08540, United States
Riverview Medical Center

Red Bank, New Jersey, 07701, United States
SIMED Health, LLC

Gainesville, Florida, 32607, United States
Saint-Quentin Hospital Center

Saint-Quentin, 02321, France
SoCal Clinical Research

Fountain Valley, California, 92708, United States
Somnos Clinical Research

Lincoln, Nebraska, 68510, United States
Southwest Family Medicine Associates

Dallas, Texas, 75235, United States
Starling Physicians

New Britain, Connecticut, 06051, United States
Sugar Lakes Family Practice, PA

Sugar Land, Texas, 77479, United States
The Jackson Clinic

Jackson, Tennessee, 38305, United States
The Vancouver Clinic

Vancouver, Washington, 98664, United States
Tidewater Physicians Multispecialty Group, P.C.

Williamsburg, Virginia, 23188, United States
Toulouse University Hospital

Toulouse, 31059, France
University of Alabama Birmingham Lung Health Center

Birmingham, Alabama, 35233, United States
VICIS Clinical Research

Tampa, Florida, 33615, United States
Valencia Medical and Research Center

Miami, Florida, 33165, United States
Vista Clinical Research

Columbia, South Carolina, 29201, United States
Vytalus Medical Group

Kingwood, Texas, 77339, United States
Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63310, United States
Wellness Clinical Research

McKinney, Texas, 75071, United States
Western Washington Medical Group, Inc

Everett, Washington, 98208, United States
Willis-Knighton Cancer Center

Shreveport, Louisiana, 71103, United States
Wilmington Health

Wilmington, North Carolina, 28401, United States
Zenith Clinical Research

Hollywood, Florida, 33024, United States

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