Screening for High Frequency Malignant Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Screening for High Frequency Malignant Disease

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Low-dose CT scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung Cancer Screening Cohort<br>Individuals at high-risk of lung cancer undergoing standard of care screening as per USPSTF guidelines. All subjects will undergo low-dose CT scanning as per guidelines and an investigational blood-draw will be taken from all enrolled subjects. | Device: Low-dose CT scan<br>* Standard of care screening for individuals at high-risk of lung cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance characteristics of Guardant LUNAR-2 test | Sensitivity, specificity, NPV, PPV | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Non-invasive diagnostics