Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation
NCT ID: NCT06838806
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-03-11
2026-03-31
Brief Summary
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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.
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Detailed Description
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Previous studies have shown that nucleosomes undergo variations during early cancer development. The Belgian company Volition has developed a blood test method based on chemiluminescence immunoassay (ChLIA) to measure nucleosomes in the blood, branded as Nu.Q™. Preliminary studies have demonstrated that Nu.Q™ can detect abnormal nucleosome biomarkers associated with early lung cancer.
This study, in collaboration with Volition, will collect 20 mL of blood samples from individuals undergoing chest LDCT. Plasma will be isolated and analyzed using Nu.Q™ at the National Taiwan University Center for Genomics and Precision Medicine. The test results will be compared with corresponding lung cancer medical records, LDCT findings, and pathological diagnoses. The study aims to enroll 500 participants.
The objectives of this study are to validate the diagnostic accuracy of the Nu.Q™ blood test for lung cancer in the Taiwanese population, compare its diagnostic performance with LDCT, and explore its potential role in lung cancer prevention and improved survival outcomes. This study is conducted as an industry-academic collaboration project with National Taiwan University.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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blood draw
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Volition Diagnostics UK Ltd
UNKNOWN
National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202412107RIND
Identifier Type: -
Identifier Source: org_study_id
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