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

NCT07182214 | Recruiting

• 1 other identifier: PHA-CPIP-LUN-A001
• Study Type: observational
• Target: 1,340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1-56 days

Study Arms (1)

control/test

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

Interventions

Collect blood sample OTHER

Collect venous blood sample from subjects prior fasting, any operation or treatment

control/test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharus Taiwan, Inc.: lead

Study Sites (1)

Pharus Taiwan, Inc.

Hsinchu, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Director of Data Science

CONTACT

+886-3-6688768; hello@pharusdx.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: May 5, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

TW (1)