Lung NoduleNCT06838806
Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation
An observational study of Lung Nodule, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Nodule
- What is being tested?
- blood draw
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2025to 31 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei
Dobbie Pei-Hsing Chen, MD, 886-2-23123456, chenph@ntu.edu.tw
About this study
Official title: Differentiating Benign and Malignant Pulmonary Nodules Using Epigenetically Modified Nucleosomes in Plasma
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.
Read the detailed description
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.
- Conditions
- Lung Nodule
- Being tested
- blood draw
- Keywords
- liquid biopsy, epigenetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
The endpoint is pathology result of diagnosis.
pathology result according to the formal pathology report.
Measured: 2 weeks
Secondary outcomes (1)
long-term cancer related outcomes
The long-term outcomes will include occurrence of Lung cancer, cancer related death and overall death.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start11 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NoduleStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Volition Diagnostics UK Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838806
- Sponsor's protocol ID
- 202412107RIND
- Status last verified
- Nov 2025
- First submitted
- 16 Feb 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating Benign and Malignant Pulmonary Nodules Using Epigenetically Modified Nucleosomes in Plasma
- ClinicalTrials.gov ID
- NCT06838806
- Acronym / sponsor ID
- 202412107RIND
- Conditions
- Lung Nodule
- Keywords
- liquid biopsy, epigenetic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Volition Diagnostics UK Ltd
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawPlasma 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). | Diagnostic test | – |
Primary outcome
The endpoint is pathology result of diagnosis.
Time frame: 2 weeks
pathology result according to the formal pathology report.
1 secondary outcome
long-term cancer related outcomes
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodule, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Hsing Chen, MD (886-2-2312-3456 Ext. 53422, chenph@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endpoint is pathology result of diagnosis. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.