Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation

NCT06838806 | Recruiting

• 1 other identifier: 202412107RIND
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Nodule

Keywords

liquid biopsy; epigenetic

Outcome Measures

Primary Outcomes (1)

• The endpoint is pathology result of diagnosis.

  pathology result according to the formal pathology report.

  2 weeks

Secondary Outcomes (1)

• long-term cancer related outcomes

  4 years

Interventions

blood draw DIAGNOSTIC_TEST

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

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study would involve collection of plasma samples with informed consent from 500 people who already receive a chest tomography or low dose chest tomography.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Volition Diagnostics UK Ltd: collaborator

Study Sites (1)

National Taiwan University

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood into a K2 EDTA tube and whole blood into a cell-free DNA BCT tube.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Pei-Hsing Chen, MD

CONTACT

886-2-2312-3456 Ext. 53422; chenph@ntu.edu.tw

Jin-Shing Chen, M.D., Ph.D.

CONTACT

86-2-2322-0322; chenjs@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 21, 2025
• Study Start: March 11, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)