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Clinical Trials in Spain / NCT05117840
Active, not recruiting Observational

Screening for High Frequency Malignant Disease

NCT05117840 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-01-13
Last updated
2026-07-06

Condition(s) studied

Lung Cancer

Investigational drug(s) / intervention(s)

Low-dose CT scan

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

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
Accepted
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 outcome measure(s)

Trial sites (143)

FacilityCityRegionStatus
University of Alabama Birmingham Lung Health Center Birmingham Alabama
Highlands Oncology Group PA Fayetteville Arkansas
Pacific Cancer Medical Center Anaheim California
Providence St. Joseph Hospital Eureka Cancer Program Eureka California
SoCal Clinical Research Fountain Valley California
Advanced Investigative Medicine Hawthorne California
Cedars-Sinai Medical Center Los Angeles California
California Medical Research Associates Inc. Northridge California
Providence Medical Foundation Santa Rosa California
Starling Physicians New Britain Connecticut
George Washington University Medical Center Washington D.C. District of Columbia
Central Florida Pulmonary Group, P.A. Altamonte Springs Florida
Pulmonary, Critical Care & Sleep Disorders Institute of South Florida Atlantis Florida
CTMD Research Coconut Creek Florida
Life Arc Research Centers Coral Gables Florida
Pulmonary Physicians of South Florida, LLC Coral Springs Florida
SIMED Health, LLC Gainesville Florida
National Research Institute Hialeah Florida
3Sync Research Hialeah Florida
Zenith Clinical Research Hollywood Florida
Multi-Specialty Research Associates, Inc. Lake City Florida
3Sync Research Lake Worth Florida
Adtremed INC Lutz Florida
Las Mias Research and Medical Center Miami Florida
Monzon Clinical Trials Miami Florida
Valencia Medical and Research Center Miami Florida
Miami Pulmonary Specialists Miami Florida
Florida Research Center, Inc. Miami Florida
Charisma Medical and Research Center Miami Lakes Florida
Adult Medicine of Lake County Mt. Dora Florida
Central Florida Pulmonary Group, P.A. Orlando Florida
Central Florida Pulmonary Group, P.A. Orlando Florida
CTMD Research Palm Springs Florida
Coastal Pulmonary and Critical Care, P.L.C. St. Petersburg Florida
Adtremed Research Clinic Tampa Florida
VICIS Clinical Research Tampa Florida
Midtown OB/GYN North Columbus Georgia
Pulmonary and Sleep Specialists of Northeast Georgia, PC Dacula Georgia
DC Research Works Marietta Georgia
Randomize Now, LLC Peachtree City Georgia

+ 103 more sites — see the full list on the official registry below.

More Guardant Health, Inc. trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05117840 on ClinicalTrials.gov ↗ ← All trials in Spain