Screening for High Frequency Malignant Disease
SHIELD
1 other identifier
observational
12,000
3 countries
143
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedStudy Start
First participant enrolled
January 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 30, 2026
March 1, 2026
5 years
November 1, 2021
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance characteristics of Guardant LUNAR-2 test
Sensitivity, specificity, NPV, PPV
36 months
Secondary Outcomes (1)
Screen detected cancer rate
36 months
Study Arms (1)
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.
Interventions
Standard of care screening for individuals at high-risk of lung cancer
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (143)
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, 35233, United States
Highlands Oncology Group PA
Fayetteville, Arkansas, 72703, United States
Pacific Cancer Medical Center
Anaheim, California, 92801, United States
Providence St. Joseph Hospital Eureka Cancer Program
Eureka, California, 95501, United States
SoCal Clinical Research
Fountain Valley, California, 92708, United States
Advanced Investigative Medicine
Hawthorne, California, 90250, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
California Medical Research Associates Inc.
Northridge, California, 91324, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Starling Physicians
New Britain, Connecticut, 06051, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
Central Florida Pulmonary Group, P.A.
Altamonte Springs, Florida, 32701, United States
Pulmonary, Critical Care & Sleep Disorders Institute of South Florida
Atlantis, Florida, 33462, United States
CTMD Research
Coconut Creek, Florida, 33063, United States
Life Arc Research Centers
Coral Gables, Florida, 33134, United States
Pulmonary Physicians of South Florida, LLC
Coral Springs, Florida, 33065, United States
SIMED Health, LLC
Gainesville, Florida, 32607, United States
National Research Institute
Hialeah, Florida, 33013, United States
3Sync Research
Hialeah, Florida, 33016, United States
Zenith Clinical Research
Hollywood, Florida, 33024, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
3Sync Research
Lake Worth, Florida, 33460, United States
Adtremed INC
Lutz, Florida, 33548, United States
Las Mias Research and Medical Center
Miami, Florida, 33144, United States
Monzon Clinical Trials
Miami, Florida, 33144, United States
Valencia Medical and Research Center
Miami, Florida, 33165, United States
Miami Pulmonary Specialists
Miami, Florida, 33173, United States
Florida Research Center, Inc.
Miami, Florida, 33174, United States
Charisma Medical and Research Center
Miami Lakes, Florida, 33014, United States
Adult Medicine of Lake County
Mt. Dora, Florida, 32757, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32825, United States
CTMD Research
Palm Springs, Florida, 33406, United States
Coastal Pulmonary and Critical Care, P.L.C.
St. Petersburg, Florida, 33704, United States
Adtremed Research Clinic
Tampa, Florida, 33607, United States
VICIS Clinical Research
Tampa, Florida, 33615, United States
Midtown OB/GYN North
Columbus, Georgia, 31901, United States
Pulmonary and Sleep Specialists of Northeast Georgia, PC
Dacula, Georgia, 30019, United States
DC Research Works
Marietta, Georgia, 30060, United States
Randomize Now, LLC
Peachtree City, Georgia, 30269, United States
Pulmonary and Sleep Specialists of Northeast Georgia, PC
Winder, Georgia, 30680, United States
Christie Clinic
Champaign, Illinois, 61822, United States
Eagle Clinical Research
Chicago, Illinois, 60621, United States
Hutchinson Clinic - North Waldron
Hutchinson, Kansas, 67502, United States
MedCorps Asthma and Pulmonary Specialists
Maysville, Kentucky, 41056, United States
Family Medicine Physicians
Hammond, Louisiana, 70403, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
HealthPartners Institute
Minneapolis, Minnesota, 55440, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Family Medical Clinic of North Mississippi
Southaven, Mississippi, 38672, United States
Branson Pulmonology and Sleep Medicine
Branson, Missouri, 65616, United States
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63310, United States
Somnos Clinical Research
Lincoln, Nebraska, 68510, United States
Great Plains Health
North Platte, Nebraska, 69101, United States
Ocean Pulmonary Associates
Brick, New Jersey, 08724, United States
Ocean University Medical Center
Brick, New Jersey, 08724, United States
RespaCare
Bridgewater, New Jersey, 08807, United States
MedCorps Asthma and Pulmonary Specialists
Cape May Court House, New Jersey, 08210, United States
Pulmonary & Sleep Disorders of New Jersey
East Brunswick, New Jersey, 08816, United States
JFK University Medical Center
Edison, New Jersey, 08820, United States
Pulmonary Internists
Edison, New Jersey, 08820, United States
Pulmonary Specialists of North Jersey
Englewood, New Jersey, 07631, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
MedCorps Asthma and Pulmonary Specialists
Linwood, New Jersey, 08221, United States
Pulmonary & Sleep Disorders of New Jersey
Monroe, New Jersey, 08831, United States
John Theurer Cancer Center at Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Pulmonary Specialists of North Jersey
North Bergen, New Jersey, 07047, United States
Respiratory and Sleep Specialists, LLC
Princeton, New Jersey, 08540, United States
Riverview Medical Center
Red Bank, New Jersey, 07701, United States
North Jersey Pulmonary Associates
Ridgewood, New Jersey, 07450, United States
MedCorps Asthma and Pulmonary Specialists
Sewell, New Jersey, 08080, United States
Ocean Pulmonary Associates
Toms River, New Jersey, 08755, 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
Great Lakes Medical Research
Westfield, New York, 14787, United States
CTMD Research, Asheville
Asheville, North Carolina, 28804, United States
MacGregor Family Physicians, P.A.
Cary, North Carolina, 27518, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
Piedmont Healthcare
Statesville, North Carolina, 28625, United States
Wilmington Health
Wilmington, North Carolina, 28401, United States
Lillestol Research, LLC
Fargo, North Dakota, 58104, United States
Pulmonology Associates Inc.
Broomall, Pennsylvania, 19008, United States
Advocare Pulmonary And Sleep Specialists
Exton, Pennsylvania, 19341, United States
Advocare Pulmonary And Sleep Specialists
Lansdale, Pennsylvania, 19446, United States
Pulmonology Associates Inc.
Paoli, Pennsylvania, 19301, United States
Advocare Pulmonary And Sleep Specialists
West Chester, Pennsylvania, 19380, United States
Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108)
Wynnewood, Pennsylvania, 19096, United States
Pulmonology Associates Inc.
Wynnewood, Pennsylvania, 19096, United States
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, 19610, United States
Vista Clinical Research
Columbia, South Carolina, 29201, United States
The Jackson Clinic
Jackson, Tennessee, 38305, 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
MidSouth Independent Group
Memphis, Tennessee, 38119, United States
Mid-South Pulmonary & Sleep Specialists PC
Memphis, Tennessee, 38157, United States
Peabody Internal Medicine Inc.
Millington, Tennessee, 38053, United States
Austin Regional Clinic
Austin, Texas, 78726, United States
Premier Family Physicians
Austin, Texas, 78735, United States
ARC Clinical Research at William Cannon
Austin, Texas, 78745, United States
Pulmonary Critical Care & Sleep Associates, P.A.
Conroe, Texas, 77304, United States
Horizon Clinical Research Group
Cypress, Texas, 77429, United States
Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
El Paso Pulmonary Associates
El Paso, Texas, 79902, United States
Allure Heath at Mt. Olympus Medical Research
Friendswood, Texas, 77546, United States
Best Cancer Care & Hematology - Biopharma Informatic
Houston, Texas, 77089, United States
Huntsville Research Institute, LLC
Huntsville, Texas, 77340, United States
Vytalus Medical Group
Kingwood, Texas, 77339, United States
Covenant Health System/Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Wellness Clinical Research
McKinney, Texas, 75071, United States
PRX Research
Mesquite, Texas, 75149, United States
Oak Cliff Research
Richardson, Texas, 75081, United States
Sugar Lakes Family Practice, PA
Sugar Land, Texas, 77479, United States
Tidewater Physicians Multispecialty Group, P.C.
Williamsburg, Virginia, 23188, United States
Western Washington Medical Group, Inc
Everett, Washington, 98208, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Mayo Clinic Health System Eau Claire
Eau Claire, Wisconsin, 54703, United States
Mayo Clinic La Crosse
La Crosse, Wisconsin, 54601, United States
Centre Hospitalier d'Abbeville
Abbeville, 80142, France
CHU Amiens Picardie - Centre de Recherche Clinique
Amiens, 80054, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300, France
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, 74130, France
Hopital Bicetre
Le Kremlin-Bicêtre, 94270, France
Hopital Europeen
Marseille, 13003, France
Hopital Pasteur CHU de Nice de Pneumologie
Nice, 06001, France
Hõpital Lyon Sud
Pierre-Bénite, 69495, France
Saint-Quentin Hospital Center
Saint-Quentin, 02321, France
Hôpitaux du Léman
Thonon-les-Bains, 74200, France
Toulouse University Hospital
Toulouse, 31059, France
Clinique Teissier
Valenciennes, 59300, France
Hospital Vithas Xanit Internacional
Benalmádena, AN, 29630, Spain
Hospital Recoletas Campo Grande
Valladolid, CL, 47007, Spain
Consulta Respira
Mataró, CT, 08302, Spain
Hospital HM Montepríncipe
Boadilla del Monte, MD, 28660, Spain
Hospital HM Sanchinarro
Madrid, MD, 28050, Spain
Hospital HM Puerta del Sur
Móstoles, MD, 28938, Spain
Biospecimen
Blood draws will be taken and analyzed for all participants
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hannah Oakley
Guardant Health, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2021
First Posted
November 11, 2021
Study Start
January 13, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share