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Screening for High Frequency Malignant Disease
NCT05117840 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Low-dose CT scan
Study Locations (20)
Florida
- Central Florida Pulmonary Group, P.A. — Altamonte Springs
- Pulmonary, Critical Care & Sleep Disorders Institute of South Florida — Atlantis
- CTMD Research — Coconut Creek
- Life Arc Research Centers — Coral Gables
- Pulmonary Physicians of South Florida, LLC — Coral Springs
- SIMED Health, LLC — Gainesville
- National Research Institute — Hialeah
- 3Sync Research — Hialeah
- Zenith Clinical Research — Hollywood
California
- Pacific Cancer Medical Center — Anaheim
- Providence St. Joseph Hospital Eureka Cancer Program — Eureka
- SoCal Clinical Research — Fountain Valley
- Advanced Investigative Medicine — Hawthorne
- Cedars-Sinai Medical Center — Los Angeles
- California Medical Research Associates Inc. — Northridge
- Providence Medical Foundation — Santa Rosa
Alabama
- University of Alabama Birmingham Lung Health Center — Birmingham
Arkansas
- Highlands Oncology Group PA — Fayetteville
Connecticut
- Starling Physicians — New Britain
District of Columbia
- George Washington University Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,000 participants |
| Start Date | 2022-01-13 |
| Est. Completion | 2026-04-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05117840
The ClinicalTrials.gov registry entry for NCT05117840 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guardant Health, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Low-dose CT scan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05117840 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05117840 about?
NCT05117840 is a clinical study titled "Screening for High Frequency Malignant Disease". 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 ca...
What is the current status of trial NCT05117840?
This trial is currently active not recruiting. The enrollment target is 12,000 participants. The study started on 2022-01-13. Estimated completion is 2026-04-30.
What conditions does trial NCT05117840 study?
This clinical trial studies the following conditions: Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05117840?
The interventions under investigation include: Low-dose CT scan (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05117840?
This trial is sponsored by Guardant Health, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05117840 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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