Screening for High Frequency Malignant Disease
- Conditions
- Lung Cancer
- Interventions
- Device: Low-dose CT scan
- Registration Number
- NCT05117840
- Lead Sponsor
- Guardant Health, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lung Cancer Screening Cohort Low-dose CT scan 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.
- Primary Outcome Measures
Name Time Method Performance characteristics of Guardant LUNAR-2 test 36 months Sensitivity, specificity, NPV, PPV
- Secondary Outcome Measures
Name Time Method Screen detected cancer rate 36 months To estimate the number of screen detected cancers, early-stage and late-stage screen detected cancers per 1000 screened subjects
Trial Locations
- Locations (135)
El Paso Pulmonary Associates
🇺🇸El Paso, Texas, United States
Allure Heath at Mt. Olympus Medical Research
🇺🇸Friendswood, Texas, United States
Best Cancer Care & Hematology - Biopharma Informatic
🇺🇸Houston, Texas, United States
Huntsville Research Institute, LLC
🇺🇸Huntsville, Texas, United States
PRX Research
🇺🇸Mesquite, Texas, United States
Oak Cliff Research
🇺🇸Richardson, Texas, United States
Sugar Lakes Family Practice, PA
🇺🇸Sugar Land, Texas, United States
Tidewater Physicians Multispecialty Group, P.C.
🇺🇸Williamsburg, Virginia, United States
Western Washington Medical Group, Inc
🇺🇸Everett, Washington, United States
The Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Hospital Vithas Xanit Internacional
🇪🇸Benalmádena, AN, Spain
Horizon Clinical Research Group
🇺🇸Cypress, Texas, United States
Hopital Bicetre
🇫🇷Le Kremlin Bicetre, France
Hopital Europeen
🇫🇷Marseille, France
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
University of Alabama Birmingham Lung Health Center
🇺🇸Birmingham, Alabama, United States
Highlands Oncology Group PA
🇺🇸Fayetteville, Arkansas, United States
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Providence St. Joseph Hospital Eureka Cancer Program
🇺🇸Eureka, California, United States
SoCal Clinical Research
🇺🇸Fountain Valley, California, United States
Saint-Quentin Hospital Center
🇫🇷Saint-Quentin, France
National Institute for Clinical Research
🇺🇸Pomona, California, United States
Advanced Investigative Medicine
🇺🇸Hawthorne, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
California Medical Research Associates Inc.
🇺🇸Northridge, California, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
Starling Physicians
🇺🇸New Britain, Connecticut, United States
Central Florida Pulmonary Group, P.A.
🇺🇸Orlando, Florida, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
Pulmonary, Critical Care & Sleep Disorders Institute of South Florida
🇺🇸Atlantis, Florida, United States
Bay Area Chest Physicians, P.A.
🇺🇸Clearwater, Florida, United States
CTMD Research
🇺🇸Palm Springs, Florida, United States
Life Arc Research Centers
🇺🇸Coral Gables, Florida, United States
Pulmonary Physicians of South Florida, LLC
🇺🇸Coral Springs, Florida, United States
SIMED Health, LLC
🇺🇸Gainesville, Florida, United States
National Research Institute
🇺🇸Hialeah, Florida, United States
3Sync Research
🇺🇸Lake Worth, Florida, United States
Zenith Clinical Research
🇺🇸Hollywood, Florida, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Jorge Barros, MVPA
🇺🇸Pembroke Pines, Florida, United States
Adtremed INC
🇺🇸Lutz, Florida, United States
Charisma Medical and Research Center
🇺🇸Miami Lakes, Florida, United States
Las Mias Research and Medical Center
🇺🇸Miami, Florida, United States
Monzon Clinical Trials
🇺🇸Miami, Florida, United States
Alma Clinical Research
🇺🇸Miami, Florida, United States
Valencia Medical and Research Center
🇺🇸Miami, Florida, United States
Miami Pulmonary Specialists
🇺🇸Miami, Florida, United States
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
De La Cruz Research Center
🇺🇸Miami, Florida, United States
Adult Medicine of Lake County
🇺🇸Mount Dora, Florida, United States
Coastal Pulmonary and Critical Care, P.L.C.
🇺🇸Saint Petersburg, Florida, United States
Genesis Clinical
🇺🇸Tampa, Florida, United States
Adtremed Research Clinic
🇺🇸Tampa, Florida, United States
VICIS Clinical Research
🇺🇸Tampa, Florida, United States
Midtown OB/GYN North
🇺🇸Columbus, Georgia, United States
Pulmonary and Sleep Specialists of Northeast Georgia, PC
🇺🇸Winder, Georgia, United States
DC Research Works
🇺🇸Marietta, Georgia, United States
Randomize Now, LLC
🇺🇸Peachtree City, Georgia, United States
Christie Clinic
🇺🇸Champaign, Illinois, United States
Eagle Clinical Research
🇺🇸Chicago, Illinois, United States
Cano Research
🇺🇸Chicago, Illinois, United States
Hutchinson Clinic - North Waldron
🇺🇸Hutchinson, Kansas, United States
MedCorps Asthma and Pulmonary Specialists
🇺🇸Sewell, New Jersey, United States
Family Medicine Physicians
🇺🇸Hammond, Louisiana, United States
Willis-Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
HealthPartners Institute
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Memorial Hospital at Gulfport
🇺🇸Gulfport, Mississippi, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Family Medical Clinic of North Mississippi
🇺🇸Southaven, Mississippi, United States
Branson Pulmonology and Sleep Medicine
🇺🇸Branson, Missouri, United States
Washington University School of Medicine/Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
Great Plains Health
🇺🇸North Platte, Nebraska, United States
Ocean Pulmonary Associates
🇺🇸Toms River, New Jersey, United States
Ocean University Medical Center
🇺🇸Brick, New Jersey, United States
RespaCare
🇺🇸Bridgewater, New Jersey, United States
Pulmonary & Sleep Disorders of New Jersey
🇺🇸Monroe, New Jersey, United States
JFK University Medical Center
🇺🇸Edison, New Jersey, United States
Pulmonary Internists
🇺🇸Edison, New Jersey, United States
Pulmonary Specialists of North Jersey
🇺🇸North Bergen, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Respiratory and Sleep Specialists, LLC
🇺🇸Princeton, New Jersey, United States
John Theurer Cancer Center at Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
North Jersey Pulmonary Associates
🇺🇸Ridgewood, New Jersey, United States
Long Island Pulmonary and Sleep Medicine Associates
🇺🇸Rockville Centre, New York, United States
Kamelhar-Teller Pulmonology
🇺🇸New York, New York, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
CTMD Research, Asheville
🇺🇸Asheville, North Carolina, United States
MacGregor Family Physicians, P.A.
🇺🇸Cary, North Carolina, United States
Durham VA Medical Center
🇺🇸Durham, North Carolina, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
Wilmington Health
🇺🇸Wilmington, North Carolina, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Pulmonology Associates Inc.
🇺🇸Wynnewood, Pennsylvania, United States
Advocare Pulmonary And Sleep Specialists
🇺🇸West Chester, Pennsylvania, United States
Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108)
🇺🇸Wynnewood, Pennsylvania, United States
Berks Schuylkill Respiratory Specialists, Ltd.
🇺🇸Wyomissing, Pennsylvania, United States
Vista Clinical Research
🇺🇸Columbia, South Carolina, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Midsouth Independent Group
🇺🇸Memphis, Tennessee, United States
MidSouth Independent Group
🇺🇸Memphis, Tennessee, United States
Mid-South Pulmonary & Sleep Specialists PC
🇺🇸Memphis, Tennessee, United States
Peabody Internal Medicine Inc.
🇺🇸Millington, Tennessee, United States
Austin Regional Clinic
🇺🇸Austin, Texas, United States
Premier Family Physicians
🇺🇸Austin, Texas, United States
ARC Clinical Research at William Cannon
🇺🇸Austin, Texas, United States
Pulmonary Critical Care & Sleep Associates, P.A.
🇺🇸Conroe, Texas, United States
Vytalus Medical Group
🇺🇸Kingwood, Texas, United States
Covenant Health System/Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Wellness Clinical Research
🇺🇸McKinney, Texas, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Mayo Clinic Health System Eau Claire
🇺🇸Eau Claire, Wisconsin, United States
Mayo Clinic La Crosse
🇺🇸La Crosse, Wisconsin, United States
Centre Hospitalier d'Abbeville
🇫🇷Abbeville, France
CHU Amiens Picardie - Centre de Recherche Clinique
🇫🇷Amiens, France
Infirmerie Protestante de Lyon
🇫🇷Caluire-et-Cuire, France
Centre Hospitalier Alpes Leman
🇫🇷Contamine sur Arve, France
Hopital Pasteur CHU de Nice de Pneumologie
🇫🇷Nice, France
Hõpital Lyon Sud
🇫🇷Pierre-Bénite, France
Hôpitaux du Léman
🇫🇷Thonon-les-Bains, France
Clinique Teissier
🇫🇷Valenciennes, France
Hospital Recoletas Campo Grande
🇪🇸Valladolid, CL, Spain
Consulta Respira
🇪🇸Mataró, CT, Spain
Hospital HM Montepríncipe
🇪🇸Boadilla del Monte, MD, Spain
MD Anderson Cancer Center
🇪🇸Madrid, MD, Spain
Hospital HM Sanchinarro
🇪🇸Madrid, MD, Spain
Hospital HM Puerta del Sur
🇪🇸Móstoles, MD, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcón, MD, Spain