ctDNA Mutations and Methylation Status for Early Detection of Lung Cancer in Patients With Suspicious Lung Nodules

Starting soon

Conditions studied: Lung Nodules, Lung Cancer Screening, Suspected Lung Cancer

In brief

Lung Cancer is common in Asia and is different from lung cancer from Western countries in terms of lung cancer epidemiology and management. Lung cancer can be detected early but most early-stage lung cancer appear as lung nodules with suspicious features on imaging. Workup and surveillance for subjects with suspicious lung nodule is a clinical problem. There is no consensus and clinical practice usually varies with local epidemiology of lung diseases namely the local clinical characteristics especially with lung cancer and pulmonary tuberculosis. The clinical challenge is to address whether pulmonary nodules identified on CT screening carry short- and long-term risk for lung cancer. The main objective of this study is to test the improvement of efficiency of diagnostic evaluation with clinical parameters and ctDNA mutation/methylation profiling for artificial intelligence modeling of for early detection of lung cancer in subjects with suspicious lung nodules. The hypothesis is that ctDNA mutation and methylation will enhance early detection of lung cancer in patients with suspicious lung nodules. This is a longitudinal cohort study. A total of 200 subjects (100 from Hong Kong and 100 from Vietnam) with suspicious lung nodules on CT Thorax will be recruited. Blood samples will be collected at recruitment and subsequent 6 months follow up. ctDNA mutations and methylation with SPOTMAS Lung assays would be performed at baseline and at 6 months follow-up. The CT scan where the suspicious lung nodules were identified, will be used as baseline scan for recruitment. Recruited subjects will be arranged with a non-contrast LDCT scans at 6 months follow-up. The primary outcome measure of the study is the detection of ctDNA mutation and methylation in correlation with diagnosis of lung cancer or persistence of suspicious lung nodules. The secondary outcome measures of the study are the Sensitivity and specificity of clinical biomarkers in correctly identifying malignant lung nodule, i.e., lung cancer.

Key facts

Study ID

NCT07615556

Run by

The University of Hong Kong

People needed

200

Starts

2026-06-01

Expected to finish

2028-12-01

Last updated by the study team

2026-06-08

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 45 - 80 years;
• Suspicious lung nodules (> 0.5 - 30mm in longest diameter, non-calcified) found within the past six months, or if PET scan has been done before, the specific uptake value (SUV) should be more than 1

You may not qualify if…

• Age < 45 or > 80;
• Lung nodules of < 0.5 cm in longest diameter, or with calcification seen in imaging;
• Known lung cancer or lung metastasis before, or history of extra-pulmonary cancer;
• Active tuberculosis;
• Clinical unstable conditions including untreated ischemic heart disease or arrhythmia, uncontrolled airway disease;
• Unwillingness to undergo invasive investigation like bronchoscopy;
• Unable to provide informed written consent.

Where it is running

• University of Hong Kong Queen Mary Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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