Active Not RecruitingNot applicableNCT05117840

Screening for High Frequency Malignant Disease

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.

Checked against the public recordLast updated Jul 6, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhaseNot applicable
U.S. locations143
SponsorGuardant Health, Inc.
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Guardant Health, Inc.
Interventions being studied
Device: Low-dose CT scan
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama Birmingham Lung Health CenterBirmingham, Alabama
  • Highlands Oncology Group PAFayetteville, Arkansas
  • Pacific Cancer Medical CenterAnaheim, California
  • Providence St. Joseph Hospital Eureka Cancer ProgramEureka, California
  • SoCal Clinical ResearchFountain Valley, California
  • Advanced Investigative MedicineHawthorne, California
  • Cedars-Sinai Medical CenterLos Angeles, California
  • California Medical Research Associates Inc.Northridge, California
  • Providence Medical FoundationSanta Rosa, California
  • Starling PhysiciansNew Britain, Connecticut
  • George Washington University Medical CenterWashington D.C., District of Columbia
  • Central Florida Pulmonary Group, P.A.Altamonte Springs, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2026. Always confirm current availability with the study team.

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