Blood test for miRNA and DNA methylation markers to detect lung cancer
An Observational Study on the Assessment of Lung Cancer Using Liquid Biopsy for Collecting miRNA Expression Profile and DNA Methylation Biomarkers
This work will test whether a blood-based liquid biopsy measuring miRNA and DNA methylation can detect lung cancer in adults with lung nodules and in people with recent clear scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pharus Taiwan, Inc. Industry-sponsored |
| Locations | 1 site (Hsinchu) |
| Trial ID | NCT07182214 on ClinicalTrials.gov |
What this trial studies
This is an observational study that collects blood samples to profile circulating miRNA expression and DNA methylation in adults undergoing LDCT screening. The study enrolls a test group of treatment‑naïve patients with lung nodules or masses scheduled for a medical procedure and a control group with no significant findings or very small nodules on recent LDCT/CT. Researchers will compare the molecular profiles from liquid biopsy with imaging findings and clinical/pathologic outcomes to identify markers associated with cancer presence. The goal is to determine whether these blood-based biomarkers correlate with lung cancer and could inform future diagnostic approaches.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who are either treatment‑naïve with LDCT-identified lung nodules/masses and a scheduled procedure or people with no significant LDCT/CT findings within the prior two months.
Not a fit: People with a prior history of cancer or recent non-autologous blood transfusion and those under 18 are excluded and would not benefit from participation in this study.
Why it matters
Potential benefit: If successful, this could provide a minimally invasive blood-based biomarker to improve early detection and reduce false positives from LDCT.
How similar studies have performed: Other research on miRNA panels and DNA methylation in liquid biopsies has shown promising but mixed results and is not yet fully validated for routine clinical use.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female or male participants at least 18 years of age 2. 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. 3. Participants in the test group should be treatment naïve. 4. Ability to complete a questionnaire, comprehend and comply with the requirements of the study 5. Written informed consent, and authorization to use and disclose health information Exclusion Criteria: 1. Has any history of cancer diagnosis 2. Has received a blood transfusion (except for autologous blood transfusion) within the first two months prior to participating the trial 3. Is participating in a clinical trial (the non-intervention trial will be accepted) 4. Has taken gene therapy within one year prior to participating the trial 5. Has any vaccinations within 3 months prior to blood sample collection 6. Is currently pregnant 7. 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 this trial is running
Hsinchu
- Pharus Taiwan, Inc. — Hsinchu, Taiwan (Recruiting)
Study contacts
- Study coordinator: Director of Data Science
- Email: hello@pharusdx.com
- Phone: +886-3-6688768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.