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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.

Tracking Information
First Submitted Date November 1, 2021
First Posted Date November 11, 2021
Last Update Posted Date April 11, 2023
Actual Study Start Date January 13, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2021)		 Performance characteristics of Guardant LUNAR-2 test [ Time Frame: 36 months ]
Sensitivity, specificity, NPV, PPV
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 1, 2021)		 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening for High Frequency Malignant Disease
Official Title Screening for High Frequency Malignant Disease
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood draws will be taken and analyzed for all participants
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.
Condition Lung Cancer
Intervention Device: Low-dose CT scan
Standard of care screening for individuals at high-risk of lung cancer
Study Groups/Cohorts 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: Device: Low-dose CT scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2021)		 9000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ha Nguyen, MD 855.698.8887 shield@guardnathealth.com
Listed Location Countries France,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05117840
Other Study ID Numbers 02-MX-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Guardant Health, Inc.
Original Responsible Party Same as current
Current Study Sponsor Guardant Health, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Ha Nguyen, MD Guardant Health, Inc.
PRS Account Guardant Health, Inc.
Verification Date April 2023