An observational study in Lung Cancer, sponsored by Pharus Taiwan, Inc.. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Pharus Taiwan, Inc. · Observational
The purpose of this study is to observe whether miRNA and DNA methylation collected through liquid biopsy can serve as a biomarker for evaluating lung cancer.
The purpose of this study is to observe whether miRNA and DNA methylation collected through liquid biopsy can serve as a biomarker for evaluating lung cancer. Lung cancer is a highly prevalent and lethal cancer, ranking second among common cancers worldwide with approximately 2.21 million new cases reported in 2020, according to the World Health Organization (WHO). It also caused around 1.8 million deaths, making it the leading cause of cancer-related mortality. This trend is consistent at the national level as well. The American Cancer Society (ACS) estimates approximately 140,000 new cases of lung cancer in the United States in 2023, ranking second in incidence among common cancers and first in mortality, accounting for about one-fifth of all cancer deaths. In Taiwan, the latest statistical report from the Health Promotion Administration, Ministry of Health and Welfare (HPA) in 2020 shows that cases of lung, bronchus, and tracheal malignant tumors accounted for 13.42% of all malignant tumor cases, totaling 16,360 individuals, ranking second in incidence for both males and females and first in mortality.
Similar to most cancers, early detection of lung cancer and timely treatment can improve survival rates. Low-dose computed tomography (LDCT) is currently an internationally recognized tool for early lung cancer screening, but it has a high false-positive rate of up to 95%, leading to overdiagnosis and causing anxiety in patients waiting for diagnosis results. Furthermore, confirmatory diagnosis of lung cancer often requires surgery or biopsy, with a rate of benign cases ranging from 10% to 30% among surgical patients. Overdiagnosis leads to the waste of healthcare resources and exposes healthy individuals to unnecessary surgical risks. Therefore, if there are other effective interventions available, it would provide physicians with additional tools to evaluate lung cancer and make decisions. These interventions could include positron emission tomography (PET) or potential methods that have not yet become routine tests, such as miRNA, DNA methylation, or circulating tumor DNA (ctDNA). This study will focus on miRNA to determine if it can assist in the evaluation of lung cancer.
This clinical study is a non-randomized, non-blinded, two-arm design trial. The participants (study subjects) in test group will be individuals at least 18 years old, and have been screened for lung nodules or masses using low dose computed tomography (LDCT)/CT scan and are scheduled for an operation (not limiting to surgical excision). Subjects in the control group will be individuals who are also at least 18 years old and have had a recent LDCT/CT scan with an axial resolution of 3 mm or less, showing no significant findings displaying either no nodules, or nodules smaller than 6mm were assessed by investigators without clinically significant justification, within 2 months prior to the enrollment for this study. Real-time polymerase chain reaction (RT-qPCR) and next-generation sequencing (NGS) techniques will be employed to detect the expression profile of miRNA and DNA methylation in plasma. Tumor marker test results and relevant information will be collected for analysis, with post operation biopsy results or physician judgments based on medical images tracked within 2 months serving as the standard for evaluating the effectiveness of lung cancer assessment.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 1,340 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Pharus Taiwan, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants in the test group must have identified lung nodules or masses through low-dose computed tomography (LDCT)CT scan, and have a scheduled medical operation, which is not limited to surgical excision. Control group participants should have no significant findings in LDCT/CT scan displaying either no nodules, or nodules smaller than 6mm were assessed by investigators without clinically significant justification, through an axial resolution of 3 mm or less, within 2 months prior to their enrollment in the study.
Exclusion Criteria:
Participants in the test group must have identified lung nodules or masses through low-dose computed tomography (LDCT)CT scan, and have a scheduled medical operation, which is not limited to surgical excision. Control group participants should have no significant findings in LDCT/CT scan displaying either no nodules, or nodules smaller than 6mm were assessed by investigators without clinically significant justification.
Other: Collect blood sample
Collect venous blood sample from subjects prior fasting, any operation or treatment
To observe miRNA or DNA methylation expressions between subjects with and without lung cancers. Once the primary outcome has been reached and the hypothesis has proven true for this study, study team then will evaluate for the secondary outcome.
Time frame: 1-56 days
Plan to share: Undecided
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Pharus Taiwan, Inc.