Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06838806

Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lung Nodule

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Currently, early lung cancer screening primarily relies on low-dose computed tomography (LDCT) of the chest. However, blood tests offer a more convenient alternative. Despite this, existing blood tests lack sufficient accuracy and sensitivity for lung cancer screening. Developing a reliable blood-based screening tool could significantly enhance the detection rate and accuracy of early lung cancer screening.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. The endpoint is pathology result of diagnosis.

    Time frame: 2 weeks

    pathology result according to the formal pathology report.

Secondary outcomes

  1. long-term cancer related outcomes

    Time frame: 4 years

    The long-term outcomes will include occurrence of Lung cancer, cancer related death and overall death.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

86-2-2322-0322

Pei-Hsing Chen, MD

CONTACT

[email protected]

886-2-2312-3456 Ext. 53422

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Volition Diagnostics UK Ltd

Registry information

Official study title

Differentiating Benign and Malignant Pulmonary Nodules Using Epigenetically Modified Nucleosomes in Plasma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.