An Observational Study on the Assessment of Lung Cancer Using Liquid Biopsy for Collecting miRNA Expression Profile and DNA Methylation Biomarkers.
Recruiting · NCT07182214 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Collect blood sample
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Female or male participants at least 18 years of age
- 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.
- Participants in the test group should be treatment naïve.
- Ability to complete a questionnaire, comprehend and comply with the requirements of the study
- Written informed consent, and authorization to use and disclose health information
Exclusion criteria
- Has any history of cancer diagnosis
- Has received a blood transfusion (except for autologous blood transfusion) within the first two months prior to participating the trial
- Is participating in a clinical trial (the non-intervention trial will be accepted)
- Has taken gene therapy within one year prior to participating the trial
- Has any vaccinations within 3 months prior to blood sample collection
- Is currently pregnant
- Has any severe acute or uncontrolled chronic lung disease such as pneumonia, lung abscess, acute exacerbation of COPD or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study
Where it is running
1 location listed.
- Pharus Taiwan, Inc. - Hsinchu, Taiwan