Trials / Active Not Recruiting
Active Not RecruitingNCT05117840
Screening for High Frequency Malignant Disease
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 12,000 (estimated)
- Sponsor
- Guardant Health, Inc. · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Low-dose CT scan | Standard of care screening for individuals at high-risk of lung cancer |
Timeline
- Start date
- 2022-01-13
- Primary completion
- 2026-07-30
- Completion
- 2026-07-30
- First posted
- 2021-11-11
- Last updated
- 2026-04-03
Locations
143 sites across 3 countries: United States, France, Spain
Source: ClinicalTrials.gov record NCT05117840. Inclusion in this directory is not an endorsement.