Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation

ConditionLung Nodule

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age20+

SponsorNational Taiwan University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

The endpoint is pathology result of diagnosis.

pathology result according to the formal pathology report.

Time frame

2 weeks

Secondary outcomes

long-term cancer related outcomes

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

Time frame

4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Volition Diagnostics UK Ltd

Collaborator

Source ClinicalTrials.gov

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