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NCT05117840 Clinical Trial

Screening for High Frequency Malignant Disease

Lung Cancer Clinical Trial

— SHIELD  

Official title:
Screening for High Frequency Malignant Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05117840
Other study ID # 02-MX-002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 13, 2022
Est. completion date December 31, 2025

Study information
Verified date April 2023
Source Guardant Health, Inc.
Contact Ha Nguyen, MD
Phone 855.698.8887
Email shield@guardnathealth.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 9000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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 - 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, 2-year and additional follow-up per protocol Exclusion Criteria: - Subject has not smoked for 15 or more years - Subject has a health problem that substantially limits life expectancy and/or the ability or willingness to have curative lung surgery - Subjects undergoing diagnostic low-dose CT scan for investigation of symptoms - 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 (DMARDs) - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Low-dose CT scan
Standard of care screening for individuals at high-risk of lung cancer

Locations
Country Name City State
France Centre Hospitalier d'Abbeville Abbeville
France CHU Amiens Picardie - Centre de Recherche Clinique Amiens
France Infirmerie Protestante de Lyon Caluire-et-Cuire
France Hôpitaux du Léman Thonon-les-Bains
Spain Hospital Vithas Xanit Internacional Benalmádena AN
Spain Hospital HM Montepríncipe Boadilla del Monte MD
Spain Hospital HM Sanchinarro Madrid MD
Spain Hospital MD Anderson Cancer Center Madrid Madrid MD
Spain Consulta Respira Mataró CT
Spain Hospital HM Puerta del Sur Móstoles MD
Spain Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón MD
Spain Hospital Recoletas Campo Grande Valladolid CL
United States Central Florida Pulmonary Group, P.A. Altamonte Springs Florida
United States Pacific Cancer Medical Center Anaheim California
United States CTMD Research, Asheville Asheville North Carolina
United States Pulmonary, Critical Care & Sleep Disorders Institute of South Florida Atlantis Florida
United States ARC Clinical Research at William Cannon Austin Texas
United States Ocean Pulmonary Associates Brick New Jersey
United States RespaCare Bridgewater New Jersey
United States Pulmonology Associates Inc. Broomall Pennsylvania
United States Gabrail Cancer Center Canton Ohio
United States Christie Clinic Champaign Illinois
United States Cano Research Chicago Illinois
United States Bay Area Chest Physicians, P.A. Clearwater Florida
United States CTMD Research Coconut Creek Florida
United States Vista Clinical Research Columbia South Carolina
United States Midtown OB/GYN North Columbus Georgia
United States Pulmonary Critical Care & Sleep Associates, P.A. Conroe Texas
United States Life Arc Research Centers Coral Gables Florida
United States Pulmonary Physicians of South Florida, LLC Coral Springs Florida
United States Houston Pulmonary Sleep, Allergy, and Asthma Associates Cypress Texas
United States Southwest Family Medicine Associates Dallas Texas
United States UT Southwestern Dallas Texas
United States Durham VA Medical Center Durham North Carolina
United States Pulmonary & Sleep Disorders of New Jersey East Brunswick New Jersey
United States Mayo Clinic Health System Eau Claire Eau Claire Wisconsin
United States Pulmonary Internists Edison New Jersey
United States El Paso Pulmonary Associates El Paso Texas
United States Pulmonary Specialists of North Jersey Englewood New Jersey
United States Western Washington Medical Group, Inc Everett Washington
United States Lillestol Research, LLC Fargo North Dakota
United States Highlands Oncology Group PA Fayetteville Arkansas
United States SoCal Clinical Research Fountain Valley California
United States Mt. Olympus Medical Research Friendswood Texas
United States SIMED Health, LLC Gainesville Florida
United States National Institute for Clinical Research Garden Grove California
United States Paragon Rx Clinical Garden Grove California
United States Clinical Research of Gastonia Gastonia North Carolina
United States Advanced Investigative Medicine Hawthorne California
United States Long Island Pulmonary and Sleep Medicine Associates Hempstead New York
United States 3Sync Research Hialeah Florida
United States National Research Institute Hialeah Florida
United States Peters Medical Research High Point North Carolina
United States Cano Research Hollywood Florida
United States Best Cancer Care & Hematology - Biopharma Informatic Houston Texas
United States Hutchinson Clinic - North Waldron Hutchinson Kansas
United States The Jackson Clinic Jackson Tennessee
United States Respiratory and Sleep Specialists, LLC Kendall Park New Jersey
United States 3Sync Research Kingwood Texas
United States Mayo Clinic La Crosse La Crosse Wisconsin
United States WS-Multi-Specialty Research Associates Lake City Florida
United States 3Sync Research Lake Worth Florida
United States Somnos Clinical Research Lincoln Nebraska
United States MedCorps Asthma and Pulmonary Specialists Linwood New Jersey
United States Joe Arrington Cancer Research Lubbock Texas
United States DC Research Works Marietta Georgia
United States Wellness Clinical Research McKinney Texas
United States PRX Research Mesquite Texas
United States Alma Clinical Research Miami Florida
United States Cano Research Miami Florida
United States De La Cruz Research Center Miami Florida
United States Florida Research Center, Inc. Miami Florida
United States Las Mias Research and Medical Center Miami Florida
United States Miami Pulmonary Specialists Miami Florida
United States Monzon Clinical Trials Miami Florida
United States Valencia Medical and Research Center Miami Florida
United States Charisma Medical and Research Center Miami Lakes Florida
United States HealthPartners Institute Minneapolis Minnesota
United States Pulmonary & Sleep Disorders of New Jersey Monroe New Jersey
United States Adult Medicine of Lake County Mount Dora Florida
United States Starling Physicians New Britain Connecticut
United States Kamelhar-Teller Pulmonology New York New York
United States Pulmonary Specialists of North Jersey North Bergen New Jersey
United States Great Plains Health North Platte Nebraska
United States California Medical Research Associates Inc. Northridge California
United States Cano Research Orlando Florida
United States Central Florida Pulmonary Group, P.A. Orlando Florida
United States Central Florida Pulmonary Group, P.A. Orlando Florida
United States CTMD Research Palm Springs Florida
United States Pulmonology Associates Inc. Paoli Pennsylvania
United States Jorge Barros, MVPA Pembroke Pines Florida
United States National Institute for Clinical Research Pomona California
United States Respiratory and Sleep Specialists, LLC Princeton New Jersey
United States Oak Cliff Research Richardson Texas
United States North Jersey Pulmonary Associates Ridgewood New Jersey
United States Mayo Clinic Rochester Minnesota
United States Long Island Pulmonary and Sleep Medicine Associates Rockville Centre New York
United States Pinellas Medical Research, LLC Saint Petersburg Florida
United States MedCorps Asthma and Pulmonary Specialists Sewell New Jersey
United States Piedmont Healthcare Statesville North Carolina
United States Sugar Lakes Family Practice, PA Sugar Land Texas
United States Adtremed Research Clinic Tampa Florida
United States Genesis Clinical Tampa Florida
United States VICIS Clinical Research Tampa Florida
United States Ocean Pulmonary Associates Toms River New Jersey
United States The Vancouver Clinic Vancouver Washington
United States Great Lakes Medical Research Westfield New York
United States Tidewater Physicians Multispecialty Group, P.C. Williamsburg Virginia
United States Wilmington Health Wilmington North Carolina
United States Pulmonology Associates Inc. Wynnewood Pennsylvania
United States Pulmonology Associates Inc.Pulmonology Associates Inc. (Suite 108) Wynnewood Pennsylvania
United States Respiratory Specialists Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Guardant Health, Inc.

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Performance characteristics of Guardant LUNAR-2 test Sensitivity, specificity, NPV, PPV 36 months
Secondary Screen detected cancer rate To estimate the number of screen detected cancers, early-stage and late-stage screen detected cancers per 1000 screened subjects 36 months
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