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 (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.
Study Type
OBSERVATIONAL
Enrollment
12,000
Standard of care screening for individuals at high-risk of lung cancer
Performance characteristics of Guardant LUNAR-2 test
Sensitivity, specificity, NPV, PPV
Time frame: 36 months
Screen detected cancer rate
To estimate the number of screen detected cancers, early-stage and late-stage screen detected cancers per 1000 screened subjects
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, United States
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
...and 133 more locations