Screening for High Frequency Malignant Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Guardant Health, Inc.
- Enrollment
- 12,000
- Locations
- 252
- Primary Endpoint
- Performance characteristics of Guardant LUNAR-2 test
Study Overview
Brief 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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Lung Cancer Screening Cohort
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.
Intervention: Low-dose CT scan (Device)
Outcomes
Primary Outcomes
Performance characteristics of Guardant LUNAR-2 test
Time Frame: 36 months
Sensitivity, specificity, NPV, PPV
Secondary Outcomes
- Screen detected cancer rate(36 months)