Screening for High Frequency Malignant Disease (SHIELD)

April 27, 2026 updated by: Guardant Health, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
        • Centre Hospitalier d'Abbeville
      • Amiens, France, 80054
        • CHU Amiens Picardie - Centre de Recherche Clinique
      • Caluire-et-Cuire, France, 69300
        • Infirmerie Protestante de Lyon
      • Contamine-sur-Arve, France, 74130
        • Centre Hospitalier Alpes Leman
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre
      • Marseille, France, 13003
        • Hôpital Européen
      • Nice, France, 06001
        • Hopital Pasteur CHU de Nice de Pneumologie
      • Pierre-Bénite, France, 69495
        • Hôpital Lyon Sud
      • Saint-Quentin, France, 02321
        • Saint-Quentin Hospital Center
      • Thonon-les-Bains, France, 74200
        • Hopitaux du Leman
      • Toulouse, France, 31059
        • Toulouse University Hospital
      • Valenciennes, France, 59300
        • Clinique Teissier
  • Spain
    • AN
      • Benalmádena, AN, Spain, 29630
        • Hospital Vithas Xanit Internacional
    • CL
      • Valladolid, CL, Spain, 47007
        • Hospital Recoletas Campo Grande
    • CT
      • Mataró, CT, Spain, 08302
        • Consulta Respira
    • MD
      • Boadilla del Monte, MD, Spain, 28660
        • Hospital HM Montepríncipe
      • Madrid, MD, Spain, 28050
        • Hospital HM Sanchinarro
      • Móstoles, MD, Spain, 28938
        • Hospital HM Puerta del Sur
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham Lung Health Center
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group PA
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center
      • Eureka, California, United States, 95501
        • Providence St. Joseph Hospital Eureka Cancer Program
      • Fountain Valley, California, United States, 92708
        • SoCal Clinical Research
      • Hawthorne, California, United States, 90250
        • Advanced Investigative Medicine
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Northridge, California, United States, 91324
        • California Medical Research Associates Inc.
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation
    • Connecticut
      • New Britain, Connecticut, United States, 06051
        • Starling Physicians
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington University Medical Center
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Central Florida Pulmonary Group, P.A.
      • Atlantis, Florida, United States, 33462
        • Pulmonary, Critical Care & Sleep Disorders Institute of South Florida
      • Coconut Creek, Florida, United States, 33063
        • CTMD Research
      • Coral Gables, Florida, United States, 33134
        • Life Arc Research Centers
      • Coral Springs, Florida, United States, 33065
        • Pulmonary Physicians of South Florida, LLC
      • Gainesville, Florida, United States, 32607
        • SIMED Health, LLC
      • Hialeah, Florida, United States, 33013
        • National Research Institute
      • Hialeah, Florida, United States, 33016
        • 3Sync Research
      • Hollywood, Florida, United States, 33024
        • Zenith Clinical Research
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc.
      • Lake Worth, Florida, United States, 33460
        • 3Sync Research
      • Lutz, Florida, United States, 33548
        • Adtremed Inc
      • Miami, Florida, United States, 33174
        • Florida Research Center, Inc.
      • Miami, Florida, United States, 33165
        • Valencia Medical and Research Center
      • Miami, Florida, United States, 33144
        • Las Mias Research and Medical Center
      • Miami, Florida, United States, 33144
        • Monzon Clinical Trials
      • Miami, Florida, United States, 33173
        • Miami Pulmonary Specialists
      • Miami Lakes, Florida, United States, 33014
        • Charisma Medical and Research Center
      • Mt. Dora, Florida, United States, 32757
        • Adult Medicine of Lake County
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, P.A.
      • Orlando, Florida, United States, 32825
        • Central Florida Pulmonary Group, P.A.
      • Palm Springs, Florida, United States, 33406
        • CTMD Research
      • St. Petersburg, Florida, United States, 33704
        • Coastal Pulmonary and Critical Care, P.L.C.
      • Tampa, Florida, United States, 33607
        • Adtremed Research Clinic
      • Tampa, Florida, United States, 33615
        • VICIS Clinical Research
    • Georgia
      • Columbus, Georgia, United States, 31901
        • Midtown OB/GYN North
      • Dacula, Georgia, United States, 30019
        • Pulmonary and Sleep Specialists of Northeast Georgia, PC
      • Marietta, Georgia, United States, 30060
        • DC Research Works
      • Peachtree City, Georgia, United States, 30269
        • Randomize Now, LLC
      • Winder, Georgia, United States, 30680
        • Pulmonary and Sleep Specialists of Northeast Georgia, PC
    • Illinois
      • Champaign, Illinois, United States, 61822
        • Christie Clinic
      • Chicago, Illinois, United States, 60621
        • Eagle Clinical Research
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic - North Waldron
    • Kentucky
      • Maysville, Kentucky, United States, 41056
        • MedCorps Asthma and Pulmonary Specialists
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Family Medicine Physicians
      • Shreveport, Louisiana, United States, 71103
        • Willis-Knighton Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55440
        • HealthPartners Institute
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Memorial Hospital at Gulfport
      • Olive Branch, Mississippi, United States, 38654
        • Olive Branch Family Medical Center
      • Southaven, Mississippi, United States, 38672
        • Family Medical Clinic of North Mississippi
    • Missouri
      • Branson, Missouri, United States, 65616
        • Branson Pulmonology and Sleep Medicine
      • St Louis, Missouri, United States, 63310
        • Washington University School of Medicine/Barnes-Jewish Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
      • North Platte, Nebraska, United States, 69101
        • Great Plains Health
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Ocean University Medical Center
      • Brick, New Jersey, United States, 08724
        • Ocean Pulmonary Associates
      • Bridgewater, New Jersey, United States, 08807
        • RespaCare
      • Cape May Court House, New Jersey, United States, 08210
        • MedCorps Asthma and Pulmonary Specialists
      • East Brunswick, New Jersey, United States, 08816
        • Pulmonary & Sleep Disorders of New Jersey
      • Edison, New Jersey, United States, 08820
        • JFK University Medical Center
      • Edison, New Jersey, United States, 08820
        • Pulmonary Internists
      • Englewood, New Jersey, United States, 07631
        • Pulmonary Specialists of North Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
      • Linwood, New Jersey, United States, 08221
        • MedCorps Asthma and Pulmonary Specialists
      • Monroe, New Jersey, United States, 08831
        • Pulmonary & Sleep Disorders of New Jersey
      • Neptune City, New Jersey, United States, 07753
        • John Theurer Cancer Center at Jersey Shore University Medical Center
      • North Bergen, New Jersey, United States, 07047
        • Pulmonary Specialists of North Jersey
      • Princeton, New Jersey, United States, 08540
        • Respiratory and Sleep Specialists, LLC
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • North Jersey Pulmonary Associates
      • Sewell, New Jersey, United States, 08080
        • MedCorps Asthma and Pulmonary Specialists
      • Toms River, New Jersey, United States, 08755
        • Ocean Pulmonary Associates
    • New York
      • Hempstead, New York, United States, 11550
        • Long Island Pulmonary and Sleep Medicine Associates
      • Rockville Centre, New York, United States, 11570
        • Long Island Pulmonary and Sleep Medicine Associates
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Asheville, North Carolina, United States, 28804
        • CTMD Research, Asheville
      • Cary, North Carolina, United States, 27518
        • MacGregor Family Physicians, P.A.
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research of Gastonia
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Statesville, North Carolina, United States, 28625
        • Piedmont Healthcare
      • Wilmington, North Carolina, United States, 28401
        • Wilmington Health
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research, LLC
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • Pulmonology Associates Inc.
      • Exton, Pennsylvania, United States, 19341
        • Advocare Pulmonary And Sleep Specialists
      • Lansdale, Pennsylvania, United States, 19446
        • Advocare Pulmonary And Sleep Specialists
      • Paoli, Pennsylvania, United States, 19301
        • Pulmonology Associates Inc.
      • West Chester, Pennsylvania, United States, 19380
        • Advocare Pulmonary And Sleep Specialists
      • Wynnewood, Pennsylvania, United States, 19096
        • Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108)
      • Wynnewood, Pennsylvania, United States, 19096
        • Pulmonology Associates Inc.
      • Wyomissing, Pennsylvania, United States, 19610
        • Berks Schuylkill Respiratory Specialists, Ltd.
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Vista Clinical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic
      • Memphis, Tennessee, United States, 38104
        • MidSouth Independent Group
      • Memphis, Tennessee, United States, 38106
        • MidSouth Independent Group
      • Memphis, Tennessee, United States, 38114
        • MidSouth Independent Group
      • Memphis, Tennessee, United States, 38119
        • MidSouth Independent Group
      • Memphis, Tennessee, United States, 38157
        • Mid-South Pulmonary & Sleep Specialists PC
      • Millington, Tennessee, United States, 38053
        • Peabody Internal Medicine Inc.
    • Texas
      • Austin, Texas, United States, 78726
        • Austin Regional Clinic
      • Austin, Texas, United States, 78745
        • ARC Clinical Research at William Cannon
      • Austin, Texas, United States, 78735
        • Premier Family Physicians
      • Conroe, Texas, United States, 77304
        • Pulmonary Critical Care & Sleep Associates, P.A.
      • Cypress, Texas, United States, 77429
        • Horizon Clinical Research Group
      • Dallas, Texas, United States, 75235
        • Southwest Family Medicine Associates
      • El Paso, Texas, United States, 79902
        • El Paso Pulmonary Associates
      • Friendswood, Texas, United States, 77546
        • Allure Heath at Mt. Olympus Medical Research
      • Houston, Texas, United States, 77089
        • Best Cancer Care & Hematology - Biopharma Informatic
      • Huntsville, Texas, United States, 77340
        • Huntsville Research Institute, LLC
      • Kingwood, Texas, United States, 77339
        • Vytalus Medical Group
      • Lubbock, Texas, United States, 79410
        • Covenant Health System/Joe Arrington Cancer Research and Treatment Center
      • McKinney, Texas, United States, 75071
        • Wellness Clinical Research
      • Mesquite, Texas, United States, 75149
        • Prx Research
      • Richardson, Texas, United States, 75081
        • Oak Cliff Research
      • Sugar Land, Texas, United States, 77479
        • Sugar Lakes Family Practice, PA
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • Tidewater Physicians Multispecialty Group, P.C.
    • Washington
      • Everett, Washington, United States, 98208
        • Western Washington Medical Group, Inc
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Mayo Clinic Health System Eau Claire
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic La Crosse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung Cancer Screening Cohort
Individuals 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.
Device: Low-dose CT scan
Standard of care screening for individuals at high-risk of lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance characteristics of Guardant LUNAR-2 test
Time Frame: 36 months
Sensitivity, specificity, NPV, PPV
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screen detected cancer rate
Time Frame: 36 months
To estimate the number of screen detected cancers, early-stage and late-stage screen detected cancers per 1000 screened subjects
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guardant Health, Inc.

Investigators

  • Study Director: Hannah Oakley, Guardant Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-MX-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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