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Recruiting NCT06838806

Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation

Trial Parameters

Condition Lung Nodule
Sponsor National Taiwan University Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 20 Years
Max Age N/A
Start Date 2025-03-11
Completion 2026-03-31
Interventions
blood draw

Brief Summary

Investigators aim to evaluate the diagnostic accuracy of the Nu.Q blood test for lung cancer in the Taiwanese population and compare its diagnostic performance with low-dose computed tomography (LDCT) or computed tomography (CT). Additionally, investigators will investigate the potential role of Nu.Q in lung cancer prevention and its impact on survival outcomes. Study Method: Investigators plan to collect 20 mL of blood samples from individuals undergoing chest LDCT/CT, isolate plasma for Nu.Q™ analysis, and compare the results with corresponding lung cancer pathology findings. The estimated sample size is 500 participants.

Eligibility Criteria

Inclusion Criteria: * Aged 20 or older * Underwent a low-dose chest CT scan or a standard chest CT scan, showing lung nodules ≥ 6mm * Individuals understand the content of the consent form and are willing to participate in this study. * The lung nodule is assessed by a physician as high-risk, requiring thoracic surgery or biopsy for diagnosis Exclusion Criteria: * Pregnant women * Individuals without capacity for consent, unable to understand the content of the consent form, or unwilling to participate in this study * Assessed by a physician as unsuitable for thoracic surgery or biopsy for diagnosis

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