Clinical trial NCT05117840: Screening for High Frequency Malignant Disease
Official title: Screening for High Frequency Malignant Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Keywords: Screening
Non-invasive diagnostics
Lead sponsor: Guardant Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 12000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

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