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Lung CancerSHIELDNCT05117840

Screening for High Frequency Malignant Disease

An observational study of Lung Cancer, run by Guardant Health, Inc. at 143 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in… Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Lung Cancer
What is being tested?
Low-dose CT scan
Type of treatment
Medical device
How many people
12,000 participants
Where
143 sitesin 3 countries
Study dates
13 Jan 2022to 31 Dec 2026
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 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • Subject has quit smoking for 15 or more years
  • Subject has less than 20 pack-year smoking history
  • Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery
  • Subject undergoing low-dose CT scan of the chest for investigation of symptoms suspicious for lung cancer
  • Preexisting or history of lung cancer
  • Previously diagnosed high-risk lung lesion
Show all 12Show fewer
  • 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)
  • Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs
  • Currently receiving treatment for pneumonia
  • 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
  • Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
  • 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

Trial locations and contacts

143 sites in 3 countries.

143 sites in 3 countries

United States125 sites

  • Central Florida Pulmonary Group, P.A.

    Altamonte Springs, Florida, 32701

  • Pacific Cancer Medical Center

    Anaheim, California, 92801

  • CTMD Research, Asheville

    Asheville, North Carolina, 28804

  • Pulmonary, Critical Care & Sleep Disorders Institute of South Florida

    Atlantis, Florida, 33462

  • Austin Regional Clinic

    Austin, Texas, 78726

  • Premier Family Physicians

    Austin, Texas, 78735

  • ARC Clinical Research at William Cannon

    Austin, Texas, 78745

  • University of Alabama Birmingham Lung Health Center

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Branson Pulmonology and Sleep Medicine

    Branson, Missouri, 65616

  • Ocean Pulmonary Associates

    Brick, New Jersey, 08724

  • Ocean University Medical Center

    Brick, New Jersey, 08724

  • RespaCare

    Bridgewater, New Jersey, 08807

  • Pulmonology Associates Inc.

    Broomall, Pennsylvania, 19008

  • MedCorps Asthma and Pulmonary Specialists

    Cape May Court House, New Jersey, 08210

  • MacGregor Family Physicians, P.A.

    Cary, North Carolina, 27518

  • Christie Clinic

    Champaign, Illinois, 61822

  • CAMC Clinical Trials Center

    Charleston, West Virginia, 25304

  • Eagle Clinical Research

    Chicago, Illinois, 60621

  • CTMD Research

    Coconut Creek, Florida, 33063

  • Vista Clinical Research

    Columbia, South Carolina, 29201

  • Midtown OB/GYN North

    Columbus, Georgia, 31901

  • Pulmonary Critical Care & Sleep Associates, P.A.

    Conroe, Texas, 77304

  • Life Arc Research Centers

    Coral Gables, Florida, 33134

  • Pulmonary Physicians of South Florida, LLC

    Coral Springs, Florida, 33065

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

  • Pulmonary and Sleep Specialists of Northeast Georgia, PC

    Dacula, Georgia, 30019

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Pulmonary & Sleep Disorders of New Jersey

    East Brunswick, New Jersey, 08816

  • Mayo Clinic Health System Eau Claire

    Eau Claire, Wisconsin, 54703

  • JFK University Medical Center

    Edison, New Jersey, 08820

  • Pulmonary Internists

    Edison, New Jersey, 08820

  • El Paso Pulmonary Associates

    El Paso, Texas, 79902

  • Pulmonary Specialists of North Jersey

    Englewood, New Jersey, 07631

  • Providence St. Joseph Hospital Eureka Cancer Program

    Eureka, California, 95501

  • Western Washington Medical Group, Inc

    Everett, Washington, 98208

  • Advocare Pulmonary And Sleep Specialists

    Exton, Pennsylvania, 19341

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Highlands Oncology Group PA

    Fayetteville, Arkansas, 72703

  • SoCal Clinical Research

    Fountain Valley, California, 92708

  • Allure Heath at Mt. Olympus Medical Research

    Friendswood, Texas, 77546

  • SIMED Health, LLC

    Gainesville, Florida, 32607

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Memorial Hospital at Gulfport

    Gulfport, Mississippi, 39501

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Family Medicine Physicians

    Hammond, Louisiana, 70403

  • Advanced Investigative Medicine

    Hawthorne, California, 90250

  • Long Island Pulmonary and Sleep Medicine Associates

    Hempstead, New York, 11550

  • National Research Institute

    Hialeah, Florida, 33013

  • 3Sync Research

    Hialeah, Florida, 33016

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Zenith Clinical Research

    Hollywood, Florida, 33024

  • Best Cancer Care & Hematology - Biopharma Informatic

    Houston, Texas, 77089

  • Huntsville Research Institute, LLC

    Huntsville, Texas, 77340

  • Hutchinson Clinic - North Waldron

    Hutchinson, Kansas, 67502

  • The Jackson Clinic

    Jackson, Tennessee, 38305

  • Vytalus Medical Group

    Kingwood, Texas, 77339

  • Mayo Clinic La Crosse

    La Crosse, Wisconsin, 54601

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055

  • 3Sync Research

    Lake Worth, Florida, 33460

  • Advocare Pulmonary And Sleep Specialists

    Lansdale, Pennsylvania, 19446

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • MedCorps Asthma and Pulmonary Specialists

    Linwood, New Jersey, 08221

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Covenant Health System/Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Adtremed INC

    Lutz, Florida, 33548

  • DC Research Works

    Marietta, Georgia, 30060

  • MedCorps Asthma and Pulmonary Specialists

    Maysville, Kentucky, 41056

  • Wellness Clinical Research

    McKinney, Texas, 75071

  • Midsouth Independent Group

    Memphis, Tennessee, 38104

  • Midsouth Independent Group

    Memphis, Tennessee, 38106

  • Midsouth Independent Group

    Memphis, Tennessee, 38114

  • MidSouth Independent Group

    Memphis, Tennessee, 38119

  • Mid-South Pulmonary & Sleep Specialists PC

    Memphis, Tennessee, 38157

  • PRX Research

    Mesquite, Texas, 75149

  • Las Mias Research and Medical Center

    Miami, Florida, 33144

  • Monzon Clinical Trials

    Miami, Florida, 33144

  • Valencia Medical and Research Center

    Miami, Florida, 33165

  • Miami Pulmonary Specialists

    Miami, Florida, 33173

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • Charisma Medical and Research Center

    Miami Lakes, Florida, 33014

  • Peabody Internal Medicine Inc.

    Millington, Tennessee, 38053

  • HealthPartners Institute

    Minneapolis, Minnesota, 55440

  • Pulmonary & Sleep Disorders of New Jersey

    Monroe, New Jersey, 08831

  • Adult Medicine of Lake County

    Mt. Dora, Florida, 32757

  • John Theurer Cancer Center at Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Starling Physicians

    New Britain, Connecticut, 06051

  • Pulmonary Specialists of North Jersey

    North Bergen, New Jersey, 07047

  • Great Plains Health

    North Platte, Nebraska, 69101

  • California Medical Research Associates Inc.

    Northridge, California, 91324

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Central Florida Pulmonary Group, P.A.

    Orlando, Florida, 32803

  • Central Florida Pulmonary Group, P.A.

    Orlando, Florida, 32825

  • CTMD Research

    Palm Springs, Florida, 33406

  • Pulmonology Associates Inc.

    Paoli, Pennsylvania, 19301

  • Randomize Now, LLC

    Peachtree City, Georgia, 30269

  • Respiratory and Sleep Specialists, LLC

    Princeton, New Jersey, 08540

  • Riverview Medical Center

    Red Bank, New Jersey, 07701

  • Oak Cliff Research

    Richardson, Texas, 75081

  • North Jersey Pulmonary Associates

    Ridgewood, New Jersey, 07450

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Long Island Pulmonary and Sleep Medicine Associates

    Rockville Centre, New York, 11570

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • MedCorps Asthma and Pulmonary Specialists

    Sewell, New Jersey, 08080

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • Family Medical Clinic of North Mississippi

    Southaven, Mississippi, 38672

  • Washington University School of Medicine/Barnes-Jewish Hospital

    St Louis, Missouri, 63310

  • Coastal Pulmonary and Critical Care, P.L.C.

    St. Petersburg, Florida, 33704

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Sugar Lakes Family Practice, PA

    Sugar Land, Texas, 77479

  • Adtremed Research Clinic

    Tampa, Florida, 33607

  • VICIS Clinical Research

    Tampa, Florida, 33615

  • Ocean Pulmonary Associates

    Toms River, New Jersey, 08755

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Advocare Pulmonary And Sleep Specialists

    West Chester, Pennsylvania, 19380

  • Great Lakes Medical Research

    Westfield, New York, 14787

  • Tidewater Physicians Multispecialty Group, P.C.

    Williamsburg, Virginia, 23188

  • Wilmington Health

    Wilmington, North Carolina, 28401

  • Pulmonary and Sleep Specialists of Northeast Georgia, PC

    Winder, Georgia, 30680

  • Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108)

    Wynnewood, Pennsylvania, 19096

  • Pulmonology Associates Inc.

    Wynnewood, Pennsylvania, 19096

  • Berks Schuylkill Respiratory Specialists, Ltd.

    Wyomissing, Pennsylvania, 19610

Other trials in United States

France12 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80142

  • CHU Amiens Picardie - Centre de Recherche Clinique

    Amiens, 80054

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300

  • Centre Hospitalier Alpes Leman

    Contamine-sur-Arve, 74130

  • Hopital Bicetre

    Le Kremlin-Bicêtre, 94270

  • Hopital Europeen

    Marseille, 13003

  • Hopital Pasteur CHU de Nice de Pneumologie

    Nice, 06001

  • Hõpital Lyon Sud

    Pierre-Bénite, 69495

  • Saint-Quentin Hospital Center

    Saint-Quentin, 02321

  • Hôpitaux du Léman

    Thonon-les-Bains, 74200

  • Toulouse University Hospital

    Toulouse, 31059

  • Clinique Teissier

    Valenciennes, 59300

Other trials in France

Spain6 sites

  • Hospital Vithas Xanit Internacional

    Benalmádena, AN, 29630

  • Hospital HM Montepríncipe

    Boadilla del Monte, MD, 28660

  • Hospital HM Sanchinarro

    Madrid, MD, 28050

  • Consulta Respira

    Mataró, CT, 08302

  • Hospital HM Puerta del Sur

    Móstoles, MD, 28938

  • Hospital Recoletas Campo Grande

    Valladolid, CL, 47007

Other trials in Spain

About this study

The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.

Read the detailed description

The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.

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 (see appendixes). Within each cohort, individuals eligible for the study will be consented for the investigational blood draw and applicable questionnaires within 90 days of standard of care screening method and prior to any invasive procedure for cancer diagnosis and/or treatment (T0). Subjects will have at least 2 follow-up visits at 1 year and 2 years (T1 and T2) since the index blood draw during the study. Additional follow-up is defined per each cohort. Updated medical data, repeat investigational blood draw and study questionnaires will be collected at follow-up intervals per each cohort's study procedure.

The first cohort to be recruited will be designated as cohort A for lung cancer screening (appendix 1). Additional baskets with other cancer-risk cohorts of interest will be considered and added as the study expands. Additional appendixes will be designed for these cohorts at that time.

Conditions
Lung Cancer
Being tested
Low-dose CT scan
Keywords
Screening, Non-invasive diagnostics
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Low-dose CT scanDevice

    Standard of care screening for individuals at high-risk of lung cancer

Study groups in NCT05117840
Study groupRoleWhat they receive
Lung Cancer Screening CohortIndividuals at high-risk of lung cancer undergoing standard of care screening as per USPSTF guidelines. All subjects will undergo low-dose CT scanning as per guidelines and an investigational blood-draw will be taken from all enrolled subjects.
Receives: Device: Low-dose CT scan

What is being measured

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

  1. Performance characteristics of Guardant LUNAR-2 test

    Sensitivity, specificity, NPV, PPV

    Measured: 36 months

Secondary outcomes (1)

  1. Screen detected cancer rate

    To estimate the number of screen detected cancers, early-stage and late-stage screen detected cancers per 1000 screened subjects

    Measured: 36 months

Timeline

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

  1. First posted11 Nov 2021
  2. Study start13 Jan 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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
12,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05117840
Sponsor's protocol ID
02-MX-002
Acronym
SHIELD
Status last verified
Jul 2026
First submitted
1 Nov 2021
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Guardant Health, Inc. at 143 sites in 3 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, France, Spain. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance characteristics of Guardant LUNAR-2 test (time frame: 36 months). 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 NCT05117840.

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 6 Jul 2026.

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