Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation
Differentiating Benign and Malignant Pulmonary Nodules Using Epigenetically Modified Nucleosomes in Plasma
National Taiwan University Hospital
500 participants
Mar 11, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria3
- 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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Interventions
Plasma samples will be collected in NTU Hospital or NTUCC. ChLIA kits and all other reagents will be provided by Volition. ChLIA analysis of samples will be performed by a Volition designated laboratory in Taiwan( NTU Centres of Genomic and Precision Medicine).
Locations(1)
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NCT06838806