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History of Changes for Study: NCT05117840
Screening for High Frequency Malignant Disease (SHIELD)
Latest version (submitted April 10, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 1, 2021 None (earliest Version on record)
2 January 20, 2022 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 April 18, 2022 Study Status
4 March 22, 2023 Contacts/Locations and Study Status
5 April 10, 2023 Contacts/Locations and Study Status
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Study NCT05117840
Submitted Date:  November 1, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: 02-MX-002
Brief Title: Screening for High Frequency Malignant Disease (SHIELD)
Official Title: Screening for High Frequency Malignant Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2021
Overall Status: Not yet recruiting
Study Start: December 31, 2021
Primary Completion: December 31, 2024 [Anticipated]
Study Completion: December 31, 2025 [Anticipated]
First Submitted: November 1, 2021
First Submitted that
Met QC Criteria:		 November 1, 2021
First Posted: November 11, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 November 1, 2021
Last Update Posted: November 11, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Guardant Health, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Lung Cancer
Keywords: Screening
Non-invasive diagnostics
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Blood draws will be taken and analyzed for all participants
Enrollment: 9000 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts 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.
 Device: Low-dose CT scan
Standard of care screening for individuals at high-risk of lung cancer
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Performance characteristics of Guardant LUNAR-2 test
[ Time Frame: 36 months ]

Sensitivity, specificity, NPV, PPV
Secondary Outcome Measures:
1. Screen detected cancer rate
[ Time Frame: 36 months ]

To estimate the number of screen detected cancers, early-stage and late-stage screen detected cancers per 1000 screened subjects
Open or close this module Eligibility
Study Population: 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.
Sampling Method: Non-Probability Sample
Minimum Age: 50 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services