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Screening for High Frequency Malignant Disease (SHIELD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05117840
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : April 11, 2023
Sponsor:
Information provided by (Responsible Party):
Guardant Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Lung Cancer Device: Low-dose CT scan

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
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Study Type : Observational
Estimated Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for High Frequency Malignant Disease
Actual Study Start Date : January 13, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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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


Biospecimen Retention:   Samples With DNA
Blood draws will be taken and analyzed for all participants

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117840


Contacts
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Contact: Ha Nguyen, MD 855.698.8887 shield@guardnathealth.com

Locations
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Sponsors and Collaborators
Guardant Health, Inc.
Investigators
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Study Director: Ha Nguyen, MD Guardant Health, Inc.
More Information
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Responsible Party: Guardant Health, Inc.
ClinicalTrials.gov Identifier: NCT05117840    
Other Study ID Numbers: 02-MX-002
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guardant Health, Inc.:
Screening
Non-invasive diagnostics