Screening for High Frequency Malignant Disease

Last updated: March 11, 2025
Sponsor: Guardant Health, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Lung Cancer

Lung Disease

Cancer

Treatment

Low-dose CT scan

Clinical Study ID

NCT05117840
02-MX-002
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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 screen-relevant populations.

Eligibility Criteria

Inclusion

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 andcurrently smoke or have quit within the past 15 years

  • Undergoing or intended to undergo low dose CT scan of the chest for lung cancerscreening

  • Willing to consent to the investigational blood draw during index LDCT screeningvisit 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

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 theability or willingness to have curative lung surgery

  4. Subject undergoing low-dose CT scan of the chest for investigation of symptomssuspicious 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 skinsquamous 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 ofinformed consent

  11. Known medical condition which, in the opinion of the investigator, should precludeenrollment into the study

  12. Participation in a clinical research study in which an experimental medicationand/or medical procedure has been administered or may be administered within the 30days leading up to providing informed consent or may be administered through thetime of subject screening

Study Design

Total Participants: 12000
Treatment Group(s): 1
Primary Treatment: Low-dose CT scan
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Centre Hospitalier d'Abbeville

    Abbeville, 80142
    France

    Site Not Available

  • CHU Amiens Picardie - Centre de Recherche Clinique

    Amiens, 80054
    France

    Site Not Available

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300
    France

    Site Not Available

  • Centre Hospitalier Alpes Leman

    Contamine sur Arve, 74130
    France

    Site Not Available

  • Hopital Bicetre

    Le Kremlin Bicetre, 94270
    France

    Site Not Available

  • Hopital Europeen

    Marseille, 13003
    France

    Site Not Available

  • Hopital Pasteur CHU de Nice de Pneumologie

    Nice, 06001
    France

    Site Not Available

  • Hõpital Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Saint-Quentin Hospital Center

    Saint-Quentin, 02321
    France

    Site Not Available

  • Hôpitaux du Léman

    Thonon-les-Bains, 74200
    France

    Site Not Available

  • Clinique Teissier

    Valenciennes, 59300
    France

    Site Not Available

  • Hospital Vithas Xanit Internacional

    Benalmádena, AN 29630
    Spain

    Site Not Available

  • Hospital Recoletas Campo Grande

    Valladolid, CL 47007
    Spain

    Site Not Available

  • Consulta Respira

    Mataró, CT 08302
    Spain

    Site Not Available

  • Hospital HM Montepríncipe

    Boadilla del Monte, MD 28660
    Spain

    Site Not Available

  • Hospital HM Sanchinarro

    Madrid, MD 28050
    Spain

    Site Not Available

  • Hospital MD Anderson Cancer Center Madrid

    Madrid, MD 28033
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center

    Madrid, MD 28033
    Spain

    Site Not Available

  • Hospital HM Puerta del Sur

    Móstoles, MD 28938
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, MD 28223
    Spain

    Site Not Available

  • University of Alabama Birmingham Lung Health Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Highlands Oncology Group PA

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Pacific Cancer Medical Center

    Anaheim, California 92801
    United States

    Site Not Available

  • Providence St. Joseph Hospital Eureka Cancer Program

    Eureka, California 95501
    United States

    Site Not Available

  • SoCal Clinical Research

    Fountain Valley, California 92708
    United States

    Site Not Available

  • National Institute for Clinical Research

    Garden Grove, California 92844
    United States

    Site Not Available

  • Paragon Rx Clinical

    Garden Grove, California 92840
    United States

    Active - Recruiting

  • Advanced Investigative Medicine

    Hawthorne, California 90250
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • California Medical Research Associates Inc.

    Northridge, California 91324
    United States

    Site Not Available

  • National Institute for Clinical Research

    Pomona, California 91768
    United States

    Site Not Available

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Starling Physicians

    New Britain, Connecticut 06051
    United States

    Site Not Available

  • George Washington University Medical Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Central Florida Pulmonary Group, P.A.

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

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

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Bay Area Chest Physicians, P.A.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • CTMD Research

    Coconut Creek, Florida 33063
    United States

    Site Not Available

  • Life Arc Research Centers

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Pulmonary Physicians of South Florida, LLC

    Coral Springs, Florida 33065
    United States

    Site Not Available

  • SIMED Health, LLC

    Gainesville, Florida 32607
    United States

    Site Not Available

  • 3Sync Research

    Hialeah, Florida 33016
    United States

    Site Not Available

  • National Research Institute

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Cano Research

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Zenith Clinical Research

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida 32055
    United States

    Site Not Available

  • WS-Multi-Specialty Research Associates

    Lake City, Florida 32055
    United States

    Active - Recruiting

  • 3Sync Research

    Lake Worth, Florida 33460
    United States

    Site Not Available

  • Adtremed INC

    Lutz, Florida 33548
    United States

    Site Not Available

  • Alma Clinical Research

    Miami, Florida 33165
    United States

    Site Not Available

  • Cano Research

    Miami, Florida 33144
    United States

    Active - Recruiting

  • De La Cruz Research Center

    Miami, Florida 33184
    United States

    Site Not Available

  • Florida Research Center, Inc.

    Miami, Florida 33174
    United States

    Site Not Available

  • Las Mias Research and Medical Center

    Miami, Florida 33144
    United States

    Site Not Available

  • Miami Pulmonary Specialists

    Miami, Florida 33173
    United States

    Site Not Available

  • Monzon Clinical Trials

    Miami, Florida 33144
    United States

    Site Not Available

  • Valencia Medical and Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Charisma Medical and Research Center

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Adult Medicine of Lake County

    Mount Dora, Florida 32757
    United States

    Site Not Available

  • Cano Research

    Orlando, Florida 32811
    United States

    Active - Recruiting

  • Central Florida Pulmonary Group, P.A.

    Orlando, Florida 32803
    United States

    Site Not Available

  • CTMD Research

    Palm Springs, Florida 33406
    United States

    Site Not Available

  • Jorge Barros, MVPA

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

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

    Saint Petersburg, Florida 33704
    United States

    Site Not Available

  • Pinellas Medical Research, LLC

    Saint Petersburg, Florida 33704
    United States

    Active - Recruiting

  • Adtremed Research Clinic

    Tampa, Florida 33607
    United States

    Site Not Available

  • Genesis Clinical

    Tampa, Florida 33603
    United States

    Site Not Available

  • VICIS Clinical Research

    Tampa, Florida 33615
    United States

    Site Not Available

  • Midtown OB/GYN North

    Columbus, Georgia 31901
    United States

    Site Not Available

  • Pulmonary and Sleep Specialists of Northeast Georgia, PC

    Dacula, Georgia 30019
    United States

    Site Not Available

  • DC Research Works

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Randomize Now, LLC

    Peachtree City, Georgia 30269
    United States

    Site Not Available

  • Pulmonary and Sleep Specialists of Northeast Georgia, PC

    Winder, Georgia 30680
    United States

    Site Not Available

  • Christie Clinic

    Champaign, Illinois 61822
    United States

    Site Not Available

  • Cano Research

    Chicago, Illinois 60638
    United States

    Site Not Available

  • Eagle Clinical Research

    Chicago, Illinois 60621
    United States

    Site Not Available

  • Hutchinson Clinic - North Waldron

    Hutchinson, Kansas 67502
    United States

    Site Not Available

  • MedCorps Asthma and Pulmonary Specialists

    Maysville, Kentucky 41056
    United States

    Site Not Available

  • Family Medicine Physicians

    Hammond, Louisiana 70403
    United States

    Site Not Available

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • HealthPartners Institute

    Minneapolis, Minnesota 55440
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Memorial Hospital at Gulfport

    Gulfport, Mississippi 39501
    United States

    Site Not Available

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi 38654
    United States

    Site Not Available

  • Family Medical Clinic of North Mississippi

    Southaven, Mississippi 38672
    United States

    Site Not Available

  • Branson Pulmonology and Sleep Medicine

    Branson, Missouri 65616
    United States

    Site Not Available

  • Washington University School of Medicine/Barnes-Jewish Hospital

    Saint Louis, Missouri 63310
    United States

    Site Not Available

  • Washington University School of Medicine/Barnes-Jewish Hospital

    St. Louis, Missouri 63310
    United States

    Site Not Available

  • Somnos Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Great Plains Health

    North Platte, Nebraska 69101
    United States

    Site Not Available

  • Ocean Pulmonary Associates

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Ocean University Medical Center

    Brick, New Jersey 08724
    United States

    Site Not Available

  • RespaCare

    Bridgewater, New Jersey 08807
    United States

    Site Not Available

  • MedCorps Asthma and Pulmonary Specialists

    Cape May Court House, New Jersey 08210
    United States

    Site Not Available

  • Pulmonary & Sleep Disorders of New Jersey

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • JFK University Medical Center

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Pulmonary Internists

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Pulmonary Specialists of North Jersey

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Respiratory and Sleep Specialists, LLC

    Kendall Park, New Jersey 08824
    United States

    Site Not Available

  • MedCorps Asthma and Pulmonary Specialists

    Linwood, New Jersey 08221
    United States

    Site Not Available

  • Pulmonary & Sleep Disorders of New Jersey

    Monroe, New Jersey 08831
    United States

    Site Not Available

  • John Theurer Cancer Center at Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Pulmonary Specialists of North Jersey

    North Bergen, New Jersey 07047
    United States

    Site Not Available

  • Respiratory and Sleep Specialists, LLC

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Riverview Medical Center

    Red Bank, New Jersey 07701
    United States

    Site Not Available

  • North Jersey Pulmonary Associates

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • MedCorps Asthma and Pulmonary Specialists

    Sewell, New Jersey 08080
    United States

    Site Not Available

  • Ocean Pulmonary Associates

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Long Island Pulmonary and Sleep Medicine Associates

    Hempstead, New York 11550
    United States

    Site Not Available

  • Kamelhar-Teller Pulmonology

    New York, New York 10016
    United States

    Site Not Available

  • Long Island Pulmonary and Sleep Medicine Associates

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Great Lakes Medical Research

    Westfield, New York 14787
    United States

    Site Not Available

  • CTMD Research, Asheville

    Asheville, North Carolina 28804
    United States

    Site Not Available

  • MacGregor Family Physicians, P.A.

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Durham VA Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Clinical Research of Gastonia

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Peters Medical Research

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Wilmington Health

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Lillestol Research, LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • Pulmonology Associates Inc.

    Broomall, Pennsylvania 19008
    United States

    Site Not Available

  • Advocare Pulmonary And Sleep Specialists

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Advocare Pulmonary And Sleep Specialists

    Lansdale, Pennsylvania 19446
    United States

    Site Not Available

  • Pulmonology Associates Inc.

    Paoli, Pennsylvania 19301
    United States

    Site Not Available

  • Advocare Pulmonary And Sleep Specialists

    West Chester, Pennsylvania 19380
    United States

    Site Not Available

  • Pulmonology Associates Inc.

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

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

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Berks Schuylkill Respiratory Specialists, Ltd.

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Respiratory Specialists

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

  • Vista Clinical Research

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Mid-South Pulmonary & Sleep Specialists PC

    Memphis, Tennessee 38157
    United States

    Site Not Available

  • MidSouth Independent Group

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Midsouth Independent Group

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Peabody Internal Medicine Inc.

    Millington, Tennessee 38053
    United States

    Site Not Available

  • ARC Clinical Research at William Cannon

    Austin, Texas 78745
    United States

    Site Not Available

  • Austin Regional Clinic

    Austin, Texas 78726
    United States

    Site Not Available

  • Premier Family Physicians

    Austin, Texas 78735
    United States

    Site Not Available

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

    Conroe, Texas 77304
    United States

    Site Not Available

  • Horizon Clinical Research Group

    Cypress, Texas 77429
    United States

    Site Not Available

  • Houston Pulmonary Sleep, Allergy, and Asthma Associates

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Site Not Available

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • El Paso Pulmonary Associates

    El Paso, Texas 79902
    United States

    Site Not Available

  • Allure Heath at Mt. Olympus Medical Research

    Friendswood, Texas 77546
    United States

    Site Not Available

  • Mt. Olympus Medical Research

    Friendswood, Texas 77546
    United States

    Active - Recruiting

  • Best Cancer Care & Hematology - Biopharma Informatic

    Houston, Texas 77089
    United States

    Site Not Available

  • Huntsville Research Institute, LLC

    Huntsville, Texas 77340
    United States

    Site Not Available

  • 3Sync Research

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Vytalus Medical Group

    Kingwood, Texas 77339
    United States

    Site Not Available

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

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Joe Arrington Cancer Research

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • Wellness Clinical Research

    McKinney, Texas 75071
    United States

    Site Not Available

  • PRX Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Oak Cliff Research

    Richardson, Texas 75081
    United States

    Site Not Available

  • Sugar Lakes Family Practice, PA

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Tidewater Physicians Multispecialty Group, P.C.

    Williamsburg, Virginia 23188
    United States

    Site Not Available

  • Western Washington Medical Group, Inc

    Everett, Washington 98208
    United States

    Site Not Available

  • The Vancouver Clinic

    Vancouver, Washington 98664
    United States

    Site Not Available

  • CAMC Clinical Trials Center

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • Mayo Clinic Health System Eau Claire

    Eau Claire, Wisconsin 54703
    United States

    Site Not Available

  • Mayo Clinic La Crosse

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

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