Screening for High Frequency Malignant Disease (SHIELD)
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|ClinicalTrials.gov Identifier: NCT05117840|
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : April 19, 2022
|Condition or disease||Intervention/treatment|
|Lung Cancer||Device: Low-dose CT scan|
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|
|Estimated Enrollment :||9000 participants|
|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|
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
- Performance characteristics of Guardant LUNAR-2 test [ Time Frame: 36 months ]Sensitivity, specificity, NPV, PPV
- 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
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
|Contact: Erika Vento-Gaudensemail@example.com|
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28401|
|Contact: Brian Webster 910-341-3300|