RecruitingNot Applicable

An Observational Study on the Assessment of Lung Cancer Using Liquid Biopsy for Collecting miRNA Expression Profile and DNA Methylation Biomarkers.

Taiwan1,340 participantsStarted 2024-05-05

Plain-language summary

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 participate

Age range18 Years

SexALL

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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

What they're measuring

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.

Timeframe: 1-56 days

Trial details

NCT IDNCT07182214

SponsorPharus Taiwan, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

Director of Data Science

+886-3-6688768 hello@pharusdx.com

View on ClinicalTrials.gov More Lung Cancer trials