Screening for High Frequency Malignant Disease

Running, not enrolling

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT05117840

Run by

Guardant Health, Inc.

People needed

12000

Starts

2022-01-13

Expected to finish

2026-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• 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
• 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
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Central Florida Pulmonary Group, P.A. — Altamonte Springs, Florida, United States
• Pulmonary, Critical Care & Sleep Disorders Institute of South Florida — Atlantis, Florida, United States
• CTMD Research — Coconut Creek, 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 — Hialeah, Florida, United States
• Zenith Clinical Research — Hollywood, Florida, United States
• Multi-Specialty Research Associates, Inc. — Lake City, Florida, United States
• 3Sync Research — Lake Worth, Florida, United States
• Adtremed INC — Lutz, Florida, United States
• Las Mias Research and Medical Center — Miami, Florida, United States
• Monzon Clinical Trials — Miami, Florida, United States
• University of Alabama Birmingham Lung Health Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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